Hematological Disorders Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Hematological Disorders Pipeline Market Report Overview

The hematological disorders pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·        Hemostasis Tests

·        Coagulation Analyzers

·        Special Coagulation Tests

·        Hematology Tests

·        General Coagulation Tests

Key Territories ·        The US

·        Europe

·        Australia

·        South Korea

·        The UK

Key Regulatory Paths ·        510(k)

·        CE-IVD

·        TGA

·        CE

·        MDITAC

Leading Companies ·        Abionic SA

·        Abram Scientific Inc

·        Alere Inc

·        Baebies Inc

·        Beckman Coulter Inc

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Hematological disorders Pipeline Market by Segments

The key segments in the hematological disorders pipeline market are hemostasis tests, coagulation analyzers, special coagulation tests, hematology tests, and general coagulation tests among others. As of December 2023, hemostasis tests was the leading segment accounting for the highest number of products in the pipeline.

Hematological Disorders Pipeline Market Analysis by Segments, 2023 (%)

Hematological Disorders Pipeline Market Analysis by Segments, 2023 (%)

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Hematological Disorders Pipeline Market Segmentation by Territories

A few of the key territories for hematological disorders pipeline products are the US, Europe, Australia, South Korea, and United Kingdom among others. As of December 2023, the US accounted for the highest number of pipeline products.

Hematological Disorders Pipeline Market Analysis by Territories, 2023 (%)

Hematological Disorders Pipeline Market Analysis by Territories, 2023 (%)

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Hematological disorders Pipeline Market Segmentation by Regulatory Paths

A few regulatory paths followed by the hematological disorders pipeline market are 510(k), CE-IVD, TGA, CE, and MDITAC. As of December 2023, 510(k) was the most followed pathway for pipeline products in the market.

Hematological Disorders Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Hematological Disorders Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Hematological Disorders Pipeline Market – Competitive Landscape

A few of the key companies associated with the hematological disorders pipeline market are Abionic SA, Abram Scientific Inc, Alere Inc, Baebies Inc, and Beckman Coulter Inc, among others.

Abionic SA: Abionic is headquartered in Lausanne, Waadt, Switzerland. The company is a medical device company that develops, produces, and markets in vitro diagnostic devices. The company provides products such as abioSCOPE, IVD capsule, abioGUIDE, abioGUIDE application for android, iPhone and iPad, and accessories, among others. Its abioSCOPE in vitro tests are designed to deliver specific, semi-quantitative and personalized information about patients’ allergen sensitization at the point ofcare.

Abram Scientific: Abram Scientific is headquartered in San Francisco, California, the US. Abram Scientific Inc (Abram Scientific) provides a fast point-of-care (POC) coagulation diagnostics for hemostasis management.

Hematological Disorders Pipeline Market Analysis by Companies, 2023

Hematological Disorders Pipeline Market Analysis by Companies, 2023

Buy the Full Report for More Company Insights into the Hematological Disorders Pipeline Market
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Segments Covered in the Report

Hematological Disorders Pipeline Market Segments Outlook

  • Hemostasis Tests
  • Coagulation Analyzers
  • Special Coagulation Tests
  • Hematology Tests
  • General Coagulation Tests

Hematological Disorders Pipeline Market Territories Outlook

  • The US
  • Europe
  • Australia
  • South Korea
  • The UK

Hematological Disorders Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE-IVD
  • TGA
  • CE
  • MDITAC

Scope

This report provides:

  • Extensive coverage of the hematological disorders under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of hematological disorders and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report will enable you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of hematological disorders under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abionic SA
Abram Scientific Inc
Alere Inc
Analyticon Biotechnologies AG
Aptitude Medical Systems Inc
Atantares Corp
Atomo Diagnostics Ltd
Baebies Inc
Beckman Coulter Inc
Beijing Sailing Medical Technology Co Ltd
Biochip Labs Inc
BioMedica USA LLC (Inactive)
BioMedomics Inc
Biosurfit, SA
Braun Biosystems, Inc. (Inactive)
Carclo Diagnostic Solutions Ltd
Coramed Technologies, LLC
Diagnostica Stago Inc
DxDiscovery Inc
Dynasil Corporation of America
Edan Instruments Inc
EKF Diagnostics Holdings Plc
ELITechGroup Inc
Emosis SAS
Epimune GmbH
Epinex Diagnostics Inc
ET Healthcare Inc
Flobio LLC
Fraunhofer Institute for Cell Therapy and Immunology
genedrive plc
Grifols SA
Group K Diagnostics
Hansjorg Wyss Institute for Biologically Inspired Engineering
Helena Laboratories Corp
hemCheck Sweden AB
Hemex Health Inc
HemoSonics LLC
Immunostep S.L
Instrumentation Laboratory Co
IntraMed Diagnostics, LLC
Levisonics Inc
Massachusetts General Hospital
McMaster University
MiCo BioMed Co Ltd
Novametics Inc (Inactive)
Ohio State University
Optolane Technologies Inc
Pakwa Technologies
Perosphere Technologies Inc
PortaScience Inc
Prolight Diagnostics AB
Radiometer Medical ApS
Randox Laboratories Ltd
Rappaport Family Institute for Research in the Medical Science
Retham Technologies LLC
rHealth
Roche Diagnostics International Ltd
Sanguina LLC
Sekisui Diagnostics LLC
ShanMukha Innovations Pvt Ltd
Siemens Healthcare Diagnostics GmbH
Siemens Healthcare Diagnostics Inc
Siemens Healthineers AG
Silver Lake Research Corporation
SonoMedix, Inc.
SpinChip Diagnostics AS
SQI Diagnostics Inc
Stichting Lygature
T2 Biosystems Inc
The Binding Site Group Ltd
ThromboTherapeutics Inc
Tosoh Bioscience Inc
Transfusion & Transplantation Technologies (Inactive)
Universal Biosensors Inc
University of Burdwan
University of California Irvine
University of Colorado
University of Florida
University of Melbourne
University of Michigan
University of Texas Health Science Center at Houston
University of Vermont
University of Washington
VitaMe Technologies Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 9

|1.2 List of Figures 18

2 Introduction 19

2.1 Hematological Disorders Overview 19

3 Products under Development 21

3.1 Hematological Disorders – Pipeline Products by Stage of Development 21

3.2 Hematological Disorders – Pipeline Products by Segment 22

3.3 Hematological Disorders – Pipeline Products by Territory 24

3.4 Hematological Disorders – Pipeline Products by Regulatory Path 25

3.5 Hematological Disorders – Pipeline Products by Estimated Approval Date 26

3.6 Hematological Disorders – Ongoing Clinical Trials 27

4 Hematological Disorders – Pipeline Products under Development by Companies 28

4.1 Hematological Disorders Companies – Pipeline Products by Stage of Development 28

4.2 Hematological Disorders – Pipeline Products by Stage of Development 32

5 Hematological Disorders Companies and Product Overview 37

5.1 Abionic SA Company Overview 37

5.1.1 Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 37

5.2 Abram Scientific Inc Company Overview 43

5.2.1 Abram Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.3 Alere Inc Company Overview 44

5.3.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.4 Analyticon Biotechnologies AG Company Overview 45

5.4.1 Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 45

5.5 Aptitude Medical Systems Inc Company Overview 49

5.5.1 Aptitude Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.6 Atantares Corp Company Overview 50

5.6.1 Atantares Corp Pipeline Products & Ongoing Clinical Trials Overview 50

5.7 Atomo Diagnostics Ltd Company Overview 51

5.7.1 Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.8 Baebies Inc Company Overview 52

5.8.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.9 Beckman Coulter Inc Company Overview 53

5.9.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.10 Beijing Sailing Medical Technology Co Ltd Company Overview 54

5.10.1 Beijing Sailing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

5.11 Biochip Labs Inc Company Overview 55

5.11.1 Biochip Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.12 BioMedica USA LLC (Inactive) Company Overview 56

5.12.1 BioMedica USA LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 56

5.13 BioMedomics Inc Company Overview 57

5.13.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.14 Biosurfit, SA Company Overview 60

5.14.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 60

5.15 Braun Biosystems, Inc. (Inactive) Company Overview 62

5.15.1 Braun Biosystems, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 62

5.16 Carclo Diagnostic Solutions Ltd Company Overview 63

5.16.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.17 Coramed Technologies, LLC Company Overview 64

5.17.1 Coramed Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 64

5.18 Diagnostica Stago Inc Company Overview 65

5.18.1 Diagnostica Stago Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.19 DxDiscovery Inc Company Overview 73

5.19.1 DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.20 Dynasil Corporation of America Company Overview 74

5.20.1 Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 74

5.21 Edan Instruments Inc Company Overview 75

5.21.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.22 EKF Diagnostics Holdings Plc Company Overview 76

5.22.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 76

5.23 ELITechGroup Inc Company Overview 77

5.23.1 ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.24 Emosis SAS Company Overview 79

5.24.1 Emosis SAS Pipeline Products & Ongoing Clinical Trials Overview 79

5.25 Epimune GmbH Company Overview 80

5.25.1 Epimune GmbH Pipeline Products & Ongoing Clinical Trials Overview 80

5.26 Epinex Diagnostics Inc Company Overview 81

5.26.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.27 ET Healthcare Inc Company Overview 82

5.27.1 ET Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.28 Flobio LLC Company Overview 83

5.28.1 Flobio LLC Pipeline Products & Ongoing Clinical Trials Overview 83

5.29 Fraunhofer Institute for Cell Therapy and Immunology Company Overview 84

5.29.1 Fraunhofer Institute for Cell Therapy and Immunology Pipeline Products & Ongoing Clinical Trials Overview 84

5.30 genedrive plc Company Overview 85

5.30.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 85

5.31 Grifols SA Company Overview 86

5.31.1 Grifols SA Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 Group K Diagnostics Company Overview 89

5.32.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 89

5.33 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 90

5.33.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 90

5.34 Helena Laboratories Corp Company Overview 91

5.34.1 Helena Laboratories Corp Pipeline Products & Ongoing Clinical Trials Overview 91

5.35 hemCheck Sweden AB Company Overview 106

5.35.1 hemCheck Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 106

5.36 Hemex Health Inc Company Overview 107

5.36.1 Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.37 HemoSonics LLC Company Overview 108

5.37.1 HemoSonics LLC Pipeline Products & Ongoing Clinical Trials Overview 108

5.38 Immunostep S.L Company Overview 112

5.38.1 Immunostep S.L Pipeline Products & Ongoing Clinical Trials Overview 112

5.39 Instrumentation Laboratory Co Company Overview 113

5.39.1 Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 113

5.40 IntraMed Diagnostics, LLC Company Overview 114

5.40.1 IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 114

5.41 Levisonics Inc Company Overview 115

5.41.1 Levisonics Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.42 Massachusetts General Hospital Company Overview 117

5.42.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 117

5.43 McMaster University Company Overview 118

5.43.1 McMaster University Pipeline Products & Ongoing Clinical Trials Overview 118

5.44 MiCo BioMed Co Ltd Company Overview 119

5.44.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

5.45 Novametics Inc (Inactive) Company Overview 120

5.45.1 Novametics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 120

5.46 Ohio State University Company Overview 121

5.46.1 Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 121

5.47 Optolane Technologies Inc Company Overview 122

5.47.1 Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 122

5.48 Pakwa Technologies Company Overview 123

5.48.1 Pakwa Technologies Pipeline Products & Ongoing Clinical Trials Overview 123

5.49 Perosphere Technologies Inc Company Overview 124

5.49.1 Perosphere Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.50 PortaScience Inc Company Overview 127

5.50.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 127

5.51 Prolight Diagnostics AB Company Overview 129

5.51.1 Prolight Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 129

5.52 Radiometer Medical ApS Company Overview 130

5.52.1 Radiometer Medical ApS Pipeline Products & Ongoing Clinical Trials Overview 130

5.53 Randox Laboratories Ltd Company Overview 132

5.53.1 Randox Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.54 Rappaport Family Institute for Research in the Medical Science Company Overview 134

5.54.1 Rappaport Family Institute for Research in the Medical Science Pipeline Products & Ongoing Clinical Trials Overview 134

5.55 Retham Technologies LLC Company Overview 135

5.55.1 Retham Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 135

5.56 rHealth Company Overview 136

5.56.1 rHealth Pipeline Products & Ongoing Clinical Trials Overview 136

5.57 Roche Diagnostics International Ltd Company Overview 139

5.57.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 139

5.58 Sanguina LLC Company Overview 143

5.58.1 Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview 143

5.59 Sekisui Diagnostics LLC Company Overview 144

5.59.1 Sekisui Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 144

5.60 ShanMukha Innovations Pvt Ltd Company Overview 149

5.60.1 ShanMukha Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 149

5.61 Siemens Healthcare Diagnostics GmbH Company Overview 150

5.61.1 Siemens Healthcare Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 150

5.62 Siemens Healthcare Diagnostics Inc Company Overview 158

5.62.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 158

5.63 Siemens Healthineers AG Company Overview 167

5.63.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 167

5.64 Silver Lake Research Corporation Company Overview 174

5.64.1 Silver Lake Research Corporation Pipeline Products & Ongoing Clinical Trials Overview 174

5.65 SonoMedix, Inc. Company Overview 175

5.65.1 SonoMedix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 175

5.66 SpinChip Diagnostics AS Company Overview 176

5.66.1 SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 176

5.67 SQI Diagnostics Inc Company Overview 179

5.67.1 SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 179

5.68 Stichting Lygature Company Overview 180

5.68.1 Stichting Lygature Pipeline Products & Ongoing Clinical Trials Overview 180

5.69 T2 Biosystems Inc Company Overview 182

5.69.1 T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 182

5.70 The Binding Site Group Ltd Company Overview 184

5.70.1 The Binding Site Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 184

5.71 ThromboTherapeutics Inc Company Overview 185

5.71.1 ThromboTherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.72 Tosoh Bioscience Inc Company Overview 186

5.72.1 Tosoh Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 186

5.73 Transfusion & Transplantation Technologies (Inactive) Company Overview 188

5.73.1 Transfusion & Transplantation Technologies (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 188

5.74 Universal Biosensors Inc Company Overview 189

5.74.1 Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 189

5.75 University of Burdwan Company Overview 192

5.75.1 University of Burdwan Pipeline Products & Ongoing Clinical Trials Overview 192

5.76 University of California Irvine Company Overview 193

5.76.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 193

5.77 University of Colorado Company Overview 194

5.77.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 194

5.78 University of Florida Company Overview 195

5.78.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 195

5.79 University of Melbourne Company Overview 196

5.79.1 University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 196

5.80 University of Michigan Company Overview 197

5.80.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 197

5.81 University of Texas Health Science Center at Houston Company Overview 198

5.81.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 198

5.82 University of Vermont Company Overview 199

5.82.1 University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 199

5.83 University of Washington Company Overview 200

5.83.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 200

5.84 VitaMe Technologies Inc Company Overview 201

5.84.1 VitaMe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 201

6 Hematological Disorders- Recent Developments 202

6.1 Dec 05, 2023: Siemens Healthineers Appoints Vivek Kanade as New Head For Its Middle East and Africa Operations 202

6.2 Nov 30, 2023: Wilmot L. Matthews Announces Resignation as Director of SQI Diagnostics Debt Forgiveness, Voting Trust Agreement and Related Transactions 202

6.3 Nov 28, 2023: Thermo Fisher Scientific Prices Offering Of $2.5 Bln Of Senior Notes 203

6.4 Nov 27, 2023: Siemens Appoints Hakan Ozdemir as CEO of Smart Infrastructure in the Middle East 203

6.5 Nov 22, 2023: Biohit Renews Its Strategy to Accelerate Profitable Growth Changes in the Management Team 203

6.6 Nov 13, 2023: ARUP receives CE mark for AAV5 DetectCDx test 204

6.7 Nov 06, 2023: Quanterix Releases Operating Results for Third Quarter 2023 205

6.8 Oct 25, 2023: Sanguina Receives CLIA Approval For AnemoCheck Home 205

6.9 Oct 25, 2023: Garuda Therapeutics Appoints Panteli Theocharous, Ph.D., FRCPath as Chief Therapeutics Officer 206

6.10 Oct 20, 2023: BioPorto to Host Third Quarter 2023 Earnings Webcast and Analyst Call 206

6.11 Oct 19, 2023: Sanguina Obtains Additional 510(k) Clearance for AnemoCheck 207

6.12 Oct 18, 2023: FloBio gets FDA breakthrough device status for bleeding risk diagnostic test 207

6.13 Oct 17, 2023: Instrumentation Laboratory Receives 510(k) Clearance for ACL TOP 970 CL Hemostasis Testing System 208

6.14 Oct 12, 2023: Birmingham Platelet Group Delivers Breakthrough ‘Nanobody’ Technology 208

6.15 Oct 05, 2023: Sanguina receives US FDA clearance for haemoglobin test kit 209

6.16 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 209

6.17 Oct 03, 2023: Baxter Appoints Joel Grade Chief Financial Officer 210

6.18 Sep 29, 2023: ARUP’s New Institute for Research and Innovation in Diagnostic and Precision Medicine Will Forge the Future of Laboratory Medicine 210

6.19 Sep 19, 2023: Perosphere Technologies Awarded Federal Grants for Point-of-Care Coagulometer 212

6.20 Sep 19, 2023: Baxter to Host Third-Quarter 2023 Financial Results Conference Call for Investors 212

6.21 Sep 18, 2023: Precision BioLogic’s Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S. 212

6.22 Sep 14, 2023: Diagnostica Stago Receives Additional 510(k) Clearance for Quantra Hemostasis Analyzer 213

6.23 Sep 11, 2023: Capitainer-backed initiative in personalized medicine and diagnostics secures a SEK 12 million boost from KK-stiftelsen 213

6.24 Sep 04, 2023: Grifols names Dr. Jorg Schüttrumpf Chief Scientific Innovation Officer 214

6.25 Aug 31, 2023: Abcam Reports Earnings Results for the Half Year Ended June 30, 2023 214

6.26 Aug 30, 2023: Approval & First Order For Xprecia Prime in India 214

6.27 Aug 28, 2023: Bio-Rad to Participate in Fireside Chat During Wells Fargo’s 2023 Healthcare Conference 215

6.28 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 215

6.29 Aug 14, 2023: Thermo Fisher Scientific to Trim Staff by More Than 200 at Florida Site 215

6.30 Aug 09, 2023: Biohit Group Announces Half Year Financial Report 2023 215

6.31 Aug 09, 2023: Halo Collective Releases Q4 2022, Q1 2023 Financial Results 232

6.32 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 234

6.33 Aug 03, 2023: HemoSonics Receives Vizient Innovative Technology Contract for Quantra Hemostasis System 234

6.34 Aug 01, 2023: Abbott Laboratories Obtains CLIA Approval for i-STAT PTPlus Cartridge With The i-STAT 1 System 235

6.35 Jul 25, 2023: iLine Microsystems Receives Additional 510(K) Clearance for microINR System 235

6.36 Jul 24, 2023: Abbott Laboratories Receives FDA 510(K) Clearance for i-STAT PTPlus Cartridge With The i-STAT 1 System 235

6.37 Jul 12, 2023: T2 Biosystems Announces Preliminary Second Quarter 2023 Financial Results 236

6.38 Jul 07, 2023: Instrumentation Laboratory Receives Additional 510(k) Clearance for HemosIL Liquid Anti – Xa Assay 237

6.39 Jul 07, 2023: Instrumentation Laboratory Receives 510(k) Clearance for ACL TOP Family 70 Series 237

6.40 Jul 06, 2023: Trinity Biotech Announces Q1 2023 Financial Results 237

6.41 Jul 05, 2023: Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, July 26, 2023 241

6.42 Jul 03, 2023: Xprecia Business Update 241

6.43 Jun 29, 2023: FDA Approves Arup Laboratories’ AAV5 Detectcdx, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy 241

6.44 Jun 20, 2023: Siemens Healthcare Diagnostics Receives 510(k) Clearance for vWF Ag Test 242

6.45 Jun 14, 2023: Biohit Announces Decisions of the Annual General Meeting 243

6.46 Jun 14, 2023: Biohit Decisions of the Annual General Meeting 243

6.47 Jun 07, 2023: IBEX Reports Results for the Third Quarter and the Nine Months Ended April 30, 2023 244

6.48 May 30, 2023: SQI Diagnostics reports second quarter 2023 results 245

6.49 May 30, 2023: Abcam announces statement on calling an extraordinary general meeting 247

6.50 May 17, 2023: STRM.BIO appoints independent director Dawn Bell, PharmD, to its board 247

6.51 May 17, 2023: ABCAM Result of Annual General Meeting 248

6.52 May 17, 2023: Abcam: Statement on potential extraordinary general meeting 248

6.53 May 15, 2023: T2 Biosystems postpones reporting of first quarter 2023 financial results 248

6.54 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 249

6.55 May 10, 2023: BioPorto announces interim results for the first three months of 2023 249

6.56 May 09, 2023: Grifols delivers strong first quarter financials with 23% revenue growth and an adjusted EBITDA margin above guidance of 21% 250

6.57 May 04, 2023: Werfen signs long-term, exclusive worldwide distributor agreement with Thermo Fisher Scientific for hemostasis testing workcell 252

6.58 May 03, 2023: Halo Collective Announces Change to Board of Directors 252

6.59 Apr 28, 2023: Siemens to announce second quarter results FY 2023 253

6.60 Apr 26, 2023: Additional Follow up Order From the Foundation for Innovative New Diagnostics (Find) 253

6.61 Apr 12, 2023: Medtronic has a layoff in California 253

6.62 Apr 05, 2023: Notice convening the Annual General Meeting in BioPorto A/S 253

6.63 Apr 04, 2023: Capitainer Launches Fully Automated Sample Handler 257

6.64 Mar 30, 2023: Abcam Publication of 2022 Annual Report and Accounts and Notice of Annual General Meeting 258

6.65 Mar 30, 2023: Abcam Publication of 2022 Annual Report and Accounts and Notice of Annual General Meeting 258

6.66 Mar 29, 2023: Baxter to Host Annual Meeting of Stockholders in Virtual Format 258

6.67 Mar 28, 2023: EKF Diagnostics Holdings Announces its final results for the year ended 31 December 2022 259

6.68 Mar 27, 2023: Hemex Health awarded $3M NIH grant to bring Gazelle Hb Variant Test for sickle cell disease to US market 260

6.69 Mar 24, 2023: UBI submits Xprecia Prime 510K application to US Food & Drug Administration 261

6.70 Mar 22, 2023: Biohit Announces Annual Report 2022 261

6.71 Mar 20, 2023: IBEX Reports Results for the Second Quarter and the Six Months Ended January 31, 2023 261

6.72 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 263

6.73 Mar 13, 2023: T2 Biosystems Announces Fourth Quarter and Full Year 2022 Financial Results 263

6.74 Mar 03, 2023: Grifols Announces Full Year 2022 Earnings 264

6.75 Feb 22, 2023: Thomas Glanzmann new Grifols Executive Chairman, after Steven F. Mayer resignation 264

6.76 Feb 16, 2023: Terumo Blood and Cell Technologies’ IMUGARD platelet pooling set cleared by FDA 265

6.77 Feb 15, 2023: Biohit Announces Group Financial Statements Release 266

6.78 Feb 14, 2023: Siemens Limited announces Q1 FY 2023 results; 80% increase in PAT from continuing operations 272

6.79 Feb 09, 2023: Sysmex Announces Summary of Consolidated Financial Results for the First Nine Months of the Fiscal Year Ending March 31, 2023 273

6.80 Feb 09, 2023: Baxter Reports Fourth-Quarter and Full-Year 2022 Results 275

6.81 Feb 08, 2023: Siemens Announces Earnings Release and Financial Results for the First Quarter of Fiscal Year 2023 277

6.82 Feb 08, 2023: Sysmex Corp. Notice of Changes in Representative Directors 278

6.83 Feb 08, 2023: Siemens Announces Earnings Release Q1 FY 2023 278

6.84 Jan 27, 2023: Halo Collective Reports Q4 Revenue Increase For its Budega(TM) Retail Stores in California 281

6.85 Jan 27, 2023: New test could detect Alzheimer’s disease

3.5 years before clinical diagnosis 282

6.86 Jan 23, 2023: UBI completes Xprecia Prime clinical trial in USA 283

6.87 Jan 23, 2023: T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2022 Financial Results 283

6.88 Jan 10, 2023: Molecular You launches a new preventive solution shown to improve health outcomes over 100 days 284

6.89 Jan 08, 2023: Hologic Announces Preliminary Revenue Results for First Quarter of Fiscal 2023 284

6.90 Jan 06, 2023: Bio-Rad to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, February 16, 2023 286

6.91 Jan 05, 2023: Precision BioLogic’s Chromogenic FIX Assay FDA-cleared for sale in U.S. 286

6.92 Jan 04, 2023: Diagnostica Stago receives CLIA clearance for STA-NeoPTimal Prothrombin Test 287

6.93 Jan 03, 2023: Diagnostica Stago receives 510(k) clearance for STA-NeoPTimal Prothrombin Test 287

6.94 Jan 03, 2023: Hemcheck extends agreement regarding previously communicated project with Region Skåne 287

6.95 Jan 02, 2023: Precision BioLogic receives 510(k) clearance for CRYOcheck Chromogenic Factor IX Assay 287

6.96 Dec 20, 2022: Instrumentation Laboratory receives additional 510(k) clearance for HemosIL von Willebrand Factor Antigen 287

7 Appendix 288

7.1 Methodology 288

7.2 About GlobalData 291

7.3 Contact Us 291

7.4 Disclaimer 291

Table

Hematological Disorders – Pipeline Products by Stage of Development 21

Hematological Disorders – Pipeline Products by Segment 22

Hematological Disorders – Pipeline Products by Territory 24

Hematological Disorders – Pipeline Products by Regulatory Path 25

Hematological Disorders – Pipeline Products by Estimated Approval Date 26

Hematological Disorders – Ongoing Clinical Trials 27

Hematological Disorders Companies – Pipeline Products by Stage of Development 28

Hematological Disorders – Pipeline Products by Stage of Development 32

Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 37

Point of Care Diagnostic Test – Basophils – Product Status 37

Point of Care Diagnostic Test – Basophils – Product Description 38

Point of Care Diagnostic Test – Eosinophils – Product Status 38

Point of Care Diagnostic Test – Eosinophils – Product Description 38

Point of Care Diagnostic Test – Erythrocyte – Product Status 39

Point of Care Diagnostic Test – Erythrocyte – Product Description 39

Point of Care Diagnostic Test – Hemoglobin – Product Status 39

Point of Care Diagnostic Test – Hemoglobin – Product Description 40

Point of Care Diagnostic Test – Lymphocytes – Product Status 40

Point of Care Diagnostic Test – Lymphocytes – Product Description 40

Point of Care Diagnostic Test – Neutrophils – Product Status 41

Point of Care Diagnostic Test – Neutrophils – Product Description 41

Point of Care Diagnostic Test – Thrombocytes – Product Status 41

Point of Care Diagnostic Test – Thrombocytes – Product Description 42

Point of Care Diagnostic Test – White Blood Cells – Product Status 42

Point of Care Diagnostic Test – White Blood Cells – Product Description 42

Abram Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 43

CoagCare System – Product Status 43

CoagCare System – Product Description 43

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Afinion PT Test – Capillary Blood – Product Status 44

Afinion PT Test – Capillary Blood – Product Description 44

Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 45

Coagulyzer 1 – Product Status 45

Coagulyzer 1 – Product Description 46

Coagulyzer 2 – Product Status 46

Coagulyzer 2 – Product Description 47

Coagulyzer 4 – Product Status 47

Coagulyzer 4 – Product Description 48

Aptitude Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 49

POC Test – Trauma Coagulopathy – Product Status 49

POC Test – Trauma Coagulopathy – Product Description 49

Atantares Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Platelet Function Assay – Product Status 50

Platelet Function Assay – Product Description 50

Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

AtomoRapid – Coagulation Monitoring – Product Status 51

AtomoRapid – Coagulation Monitoring – Product Description 51

Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Digital Microfluidic System – Trauma Coagulation – Product Status 52

Digital Microfluidic System – Trauma Coagulation – Product Description 52

Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 53

SYNCHRON Lxi 725 D-Dimer Assay – Product Status 53

SYNCHRON Lxi 725 D-Dimer Assay – Product Description 53

Beijing Sailing Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Fourth-Generation Thromboelastogrpahy Device – Product Status 54

Fourth-Generation Thromboelastogrpahy Device – Product Description 54

Biochip Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Endothelium-on-a-Chip Assay – Product Status 55

Endothelium-on-a-Chip Assay – Product Description 55

BioMedica USA LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 56

Portable Diagnostic System – Hemostasis – Product Status 56

Portable Diagnostic System – Hemostasis – Product Description 56

BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Fetomaternal Hemorrhage Test – Product Status 57

Fetomaternal Hemorrhage Test – Product Description 57

Hemo SCAN – Product Status 58

Hemo SCAN – Product Description 58

Hemo SCAN S – Product Status 58

Hemo SCAN S – Product Description 59

Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test – Product Status 59

Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test – Product Description 59

Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 60

Spinit Device – Blood Quantitation Anemia Assay – Product Status 60

Spinit Device – Blood Quantitation Anemia Assay – Product Description 60

Spinit Device – Thrombocytopenia Assay – Product Status 61

Spinit Device – Thrombocytopenia Assay – Product Description 61

Braun Biosystems, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 62

Bio6 – Product Status 62

Bio6 – Product Description 62

Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Micropoc-CAT – Haemostasis Assay – Product Status 63

Micropoc-CAT – Haemostasis Assay – Product Description 63

Coramed Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 64

TEG 6000 Thrombelastograph – Product Status 64

TEG 6000 Thrombelastograph – Product Description 64

Diagnostica Stago Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Calibrated Automated Thrombogram – Thrombin Assay – Product Status 65

Calibrated Automated Thrombogram – Thrombin Assay – Product Description 66

STA Compact Max – NeoPTimal ISI – Product Status 66

STA Compact Max – NeoPTimal ISI – Product Description 66

STA Compact Max – Ristocetin Cofactor Assay – Product Status 67

STA Compact Max – Ristocetin Cofactor Assay – Product Description 67

STA Compact Max – Rivaroxaban Calibrators And Controls For Anti-Xa – Product Status 67

STA Compact Max – Rivaroxaban Calibrators And Controls For Anti-Xa – Product Description 68

STA-R Evolution Expert – Automated Ecarin Chromogenic Assay – Product Status 68

STA-R Evolution Expert – Automated Ecarin Chromogenic Assay – Product Description 68

STA-R Evolution Plus – Automated Ecarin Chromogenic Assay – Product Status 69

STA-R Evolution Plus – Automated Ecarin Chromogenic Assay – Product Description 69

STA-R Evolution Plus – Rivaroxaban and Apixaban Calibrators And Controls For Anti-Xa – Product Status 69

STA-R Evolution Plus – Rivaroxaban and Apixaban Calibrators And Controls For Anti-Xa – Product Description 70

STA-R Max – NeoPTimal ISI – Product Status 70

STA-R Max – NeoPTimal ISI – Product Description 70

STA-R Max – Ristocetin Cofactor Assay – Product Status 71

STA-R Max – Ristocetin Cofactor Assay – Product Description 71

STA-R Max – Rivaroxaban Calibrators And Controls For Anti-Xa – Product Status 71

STA-R Max – Rivaroxaban Calibrators And Controls For Anti-Xa – Product Description 72

DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Diagnostic Assay – Sickle Cell Disease – Product Status 73

Diagnostic Assay – Sickle Cell Disease – Product Description 73

Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 74

Diagnostic Test – Hemophilia – Product Status 74

Diagnostic Test – Hemophilia – Product Description 74

Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 75

i15 – Coagulation Test – Product Status 75

i15 – Coagulation Test – Product Description 75

EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 76

Point-Of-Care Test – Coagulation – Product Status 76

Point-Of-Care Test – Coagulation – Product Description 76

ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 77

Selectra ProM Chemistry System – D-dimer Assay – Product Status 77

Selectra ProM Chemistry System – D-dimer Assay – Product Description 77

Selectra ProS Chemistry System – D-dimer Assay – Product Status 78

Selectra ProS Chemistry System – D-dimer Assay – Product Description 78

Emosis SAS Pipeline Products & Ongoing Clinical Trials Overview 79

ClotSeek – Product Status 79

ClotSeek – Product Description 79

Epimune GmbH Pipeline Products & Ongoing Clinical Trials Overview 80

i.Mune Tbnk Test – Product Status 80

i.Mune Tbnk Test – Product Description 80

Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Epinex SimplySure PT-INR Test – Product Status 81

Epinex SimplySure PT-INR Test – Product Description 81

ET Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 82

Pylon Assay – D-Dimer – Product Status 82

Pylon Assay – D-Dimer – Product Description 82

Flobio LLC Pipeline Products & Ongoing Clinical Trials Overview 83

DOAC Diagnostic Assay – Product Status 83

DOAC Diagnostic Assay – Product Description 83

Fraunhofer Institute for Cell Therapy and Immunology Pipeline Products & Ongoing Clinical Trials Overview 84

Point-Of-Care Assay – Primary And Secondary Hemostasis – Product Status 84

Point-Of-Care Assay – Primary And Secondary Hemostasis – Product Description 84

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 85

Genedrive – Factor V Leiden – Product Status 85

Genedrive – Factor V Leiden – Product Description 85

Grifols SA Pipeline Products & Ongoing Clinical Trials Overview 86

Hemostasis Reagent Kit – DG-APTT Synth G-Fib L Human – Product Status 86

Hemostasis Reagent Kit – DG-APTT Synth G-Fib L Human – Product Description 86

Hemostasis Reagent Kit – DG-Latex D Dimer – Product Status 87

Hemostasis Reagent Kit – DG-Latex D Dimer – Product Description 87

Hemostasis Reagent Kit – DG-Latex VWF: Gp1b – Product Status 87

Hemostasis Reagent Kit – DG-Latex VWF: Gp1b – Product Description 88

Hemostasis Reagent Kit – DG-TT L Human – Product Status 88

Hemostasis Reagent Kit – DG-TT L Human – Product Description 88

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 89

KromaHealth Kit – Complete Blood Count – Product Status 89

KromaHealth Kit – Complete Blood Count – Product Description 89

Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 90

Hemostasis Monitoring Microfluidic Device – Product Status 90

Hemostasis Monitoring Microfluidic Device – Product Description 90

Helena Laboratories Corp Pipeline Products & Ongoing Clinical Trials Overview 91

Actalyke Mini II – APTT Test – Product Status 92

Actalyke Mini II – APTT Test – Product Description 92

Actalyke Mini II – LMWH Test – Product Status 92

Actalyke Mini II – LMWH Test – Product Description 93

Actalyke Mini II – PT Test – Product Status 93

Actalyke Mini II – PT Test – Product Description 93

Actalyke XL – APTT Test – Product Status 94

Actalyke XL – APTT Test – Product Description 94

Actalyke XL – Heparin Test – Product Status 94

Actalyke XL – Heparin Test – Product Description 95

Actalyke XL – LMWH Test – Product Status 95

Actalyke XL – LMWH Test – Product Description 95

Actalyke XL – PT Test – Product Status 96

Actalyke XL – PT Test – Product Description 96

AggRAM – Chromogenic Test – Product Status 96

AggRAM – Chromogenic Test – Product Description 97

AggRAM – HIT Test – Product Status 97

AggRAM – HIT Test – Product Description 97

AggRAM – Lumi Test – Product Status 97

AggRAM – Lumi Test – Product Description 98

Cascade Abrazo – c-ACT-LR – Product Status 98

Cascade Abrazo – c-ACT-LR – Product Description 98

Cascade Abrazo – Direct Oral Anticoagulants Test – Product Status 99

Cascade Abrazo – Direct Oral Anticoagulants Test – Product Description 99

Cascade Abrazo – Direct Thrombin Inhibitors – Product Status 99

Cascade Abrazo – Direct Thrombin Inhibitors – Product Description 100

Cascade Abrazo – Fibrinogen – Product Status 100

Cascade Abrazo – Fibrinogen – Product Description 100

Cascade Abrazo – Heparin Titration – Product Status 101

Cascade Abrazo – Heparin Titration – Product Description 101

Cascade Abrazo – LMWH – Product Status 101

Cascade Abrazo – LMWH – Product Description 102

Cascade Abrazo – Protamine Titration – Product Status 102

Cascade Abrazo – Protamine Titration – Product Description 102

Cascade Abrazo – PT-C – Product Status 103

Cascade Abrazo – PT-C – Product Description 103

Cascade Abrazo Analyzer – Product Status 103

Cascade Abrazo Analyzer – Product Description 104

Cascade M – DRVVT Test – Product Status 104

Cascade M – DRVVT Test – Product Description 104

Cascade M-4 – DRVVT Test – Product Status 105

Cascade M-4 – DRVVT Test – Product Description 105

hemCheck Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 106

v-Test – Serum Tubes – Product Status 106

v-Test – Serum Tubes – Product Description 106

Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 107

Gazelle Hb Variant Test – Product Status 107

Gazelle Hb Variant Test – Product Description 107

HemoSonics LLC Pipeline Products & Ongoing Clinical Trials Overview 108

HemoSonics Global Hemostasis Analyzer – Intensive Care – Product Status 108

HemoSonics Global Hemostasis Analyzer – Intensive Care – Product Description 108

HemoSonics Global Hemostasis Analyzer – Neurosurgery – Product Status 109

HemoSonics Global Hemostasis Analyzer – Neurosurgery – Product Description 109

HemoSonics Global Hemostasis Analyzer – Orthopedic Surgery – Product Status 109

HemoSonics Global Hemostasis Analyzer – Orthopedic Surgery – Product Description 110

HemoSonics Global Hemostasis Analyzer – Trauma – Product Status 110

HemoSonics Global Hemostasis Analyzer – Trauma – Product Description 110

HemoSonics Global Hemostasis Analyzer HS-GHA – Product Status 111

HemoSonics Global Hemostasis Analyzer HS-GHA – Product Description 111

Immunostep S.L Pipeline Products & Ongoing Clinical Trials Overview 112

Bmplex Hemodilution Test – Product Status 112

Bmplex Hemodilution Test – Product Description 112

Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 113

HemosIL VWF-Ristocetin Cofactor Activity Assay – Product Status 113

HemosIL VWF-Ristocetin Cofactor Activity Assay – Product Description 113

IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 114

ProTrac Coagulation – Product Status 114

ProTrac Coagulation – Product Description 114

Levisonics Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Blood Coagulation Analyzer – Product Status 115

Blood Coagulation Analyzer – Product Description 115

Pediatric Coagulation Analyzer – Product Status 116

Pediatric Coagulation Analyzer – Product Description 116

Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 117

High Throughput Screening Assay – Fibrin-Binding Probes – Product Status 117

High Throughput Screening Assay – Fibrin-Binding Probes – Product Description 117

McMaster University Pipeline Products & Ongoing Clinical Trials Overview 118

aFXa DOAC Assay – Product Status 118

aFXa DOAC Assay – Product Description 118

MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

Labchip Based Test – Hemoglobin – Product Status 119

Labchip Based Test – Hemoglobin – Product Description 119

Novametics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 120

Blood Coagulation Diagnostic Assay – Product Status 120

Blood Coagulation Diagnostic Assay – Product Description 120

Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 121

Diagnostic Assay – Thrombotic Thrombocytopenic Purpura – Product Status 121

Diagnostic Assay – Thrombotic Thrombocytopenic Purpura – Product Description 121

Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 122

Molecular Dx – Thrombosis Panel – Product Status 122

Molecular Dx – Thrombosis Panel – Product Description 122

Pakwa Technologies Pipeline Products & Ongoing Clinical Trials Overview 123

Platelet ActiSense – Product Status 123

Platelet ActiSense – Product Description 123

Perosphere Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

PoC Coagulometer – Product Status 124

PoC Coagulometer – Product Description 124

Perosphere Technologies Inc – Ongoing Clinical Trials Overview 125

PoC Coagulometer – Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls with the Perosphere Technologies’ PoC Coagulometer 126

PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 127

PortaPT – Product Status 127

PortaPT – Product Description 127

PortaWBC – Product Status 128

PortaWBC – Product Description 128

Prolight Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 129

Point Of Care D-Dimer Test – Product Status 129

Point Of Care D-Dimer Test – Product Description 129

Radiometer Medical ApS Pipeline Products & Ongoing Clinical Trials Overview 130

AQT90 FLEX – APTT Test – Product Status 130

AQT90 FLEX – APTT Test – Product Description 130

AQT90 FLEX – PT-INR Test – Product Status 131

AQT90 FLEX – PT-INR Test – Product Description 131

Randox Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

Rx Daytona – D-dimer Assay – Product Status 132

Rx Daytona – D-dimer Assay – Product Description 132

Rx Imola D-dimer Test – Product Status 133

Rx Imola D-dimer Test – Product Description 133

Rappaport Family Institute for Research in the Medical Science Pipeline Products & Ongoing Clinical Trials Overview 134

Diagnostic Kit – Hypercoagulation – Product Status 134

Diagnostic Kit – Hypercoagulation – Product Description 134

Retham Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 135

HITDx – Product Status 135

HITDx – Product Description 135

rHealth Pipeline Products & Ongoing Clinical Trials Overview 136

Diagnostic Test – Thrombocytopenia – Product Status 136

Diagnostic Test – Thrombocytopenia – Product Description 136

Fluorogenic FVIII Assay Kit – Product Status 137

Fluorogenic FVIII Assay Kit – Product Description 137

rHEALTH Coagulation Assay – Product Status 137

rHEALTH Coagulation Assay – Product Description 138

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 139

Cobas t 511 Coagulation Analyzer – dRVVT Confirm Assay – Product Status 139

Cobas t 511 Coagulation Analyzer – dRVVT Confirm Assay – Product Description 140

Cobas t 511 Coagulation Analyzer – dRVVT Screen Assay – Product Status 140

Cobas t 511 Coagulation Analyzer – dRVVT Screen Assay – Product Description 140

Cobas t 711 Coagulation Analyzer – APCr Assay – Product Status 141

Cobas t 711 Coagulation Analyzer – APCr Assay – Product Description 141

Cobas t 711 Coagulation Analyzer – dRVVT Confirm Assay – Product Status 141

Cobas t 711 Coagulation Analyzer – dRVVT Confirm Assay – Product Description 141

Cobas t 711 Coagulation Analyzer – dRVVT Screen Assay – Product Status 142

Cobas t 711 Coagulation Analyzer – dRVVT Screen Assay – Product Description 142

Cobas t 711 Coagulation Analyzer – FXIII Assay – Product Status 142

Cobas t 711 Coagulation Analyzer – FXIII Assay – Product Description 142

Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview 143

AnemoCheck Home – Product Status 143

AnemoCheck Home – Product Description 143

Sekisui Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 144

Coapresta 2000 Chromogenic Assay – APL – Product Status 144

Coapresta 2000 Chromogenic Assay – APL – Product Description 144

Coapresta 2000 Chromogenic Assay – Heparin – Product Status 145

Coapresta 2000 Chromogenic Assay – Heparin – Product Description 145

Coapresta 2000 Chromogenic Assay – PLG – Product Status 145

Coapresta 2000 Chromogenic Assay – PLG – Product Description 146

Coapresta 2000 Clotting Time Assay – Factor XII – Product Status 146

Coapresta 2000 Clotting Time Assay – Factor XII – Product Description 146

Coapresta 2000 Clotting Time Assay – PC – Product Status 147

Coapresta 2000 Clotting Time Assay – PC – Product Description 147

Coapresta 2000 Latex Turbidimetry Assay – SF – Product Status 147

Coapresta 2000 Latex Turbidimetry Assay – SF – Product Description 148

ShanMukha Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 149

SickleFind – Product Status 149

SickleFind – Product Description 149

Siemens Healthcare Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 150

Atellica COAG 360 System – ADP – Product Status 150

Atellica COAG 360 System – ADP – Product Description 151

Atellica COAG 360 System – Arachidonic Acid Reagent – Product Status 151

Atellica COAG 360 System – Arachidonic Acid Reagent – Product Description 151

Atellica COAG 360 System – Berichrom C-1 Inhibitor Assay – Product Status 152

Atellica COAG 360 System – Berichrom C-1 Inhibitor Assay – Product Description 152

Atellica COAG 360 System – Collagen Reagent – Product Status 152

Atellica COAG 360 System – Collagen Reagent – Product Description 153

Atellica COAG 360 System – Epinephrine Reagent – Product Status 153

Atellica COAG 360 System – Epinephrine Reagent – Product Description 153

Atellica COAG 360 System – Lyophilized Platelets Reagent – Product Status 154

Atellica COAG 360 System – Lyophilized Platelets Reagent – Product Description 154

Atellica COAG 360 System – N Antiserum to Human Antithrombin III Assay – Product Status 154

Atellica COAG 360 System – N Antiserum to Human Antithrombin III Assay – Product Description 155

Atellica COAG 360 System – N Antiserum to Human C1 Inhibitor Assay – Product Status 155

Atellica COAG 360 System – N Antiserum to Human C1 Inhibitor Assay – Product Description 155

Atellica COAG 360 System – N Antiserum To Human Fibrinogen Assay – Product Status 155

Atellica COAG 360 System – N Antiserum To Human Fibrinogen Assay – Product Description 156

Atellica COAG 360 System – N Antiserum to Human Plasminogen Assay – Product Status 156

Atellica COAG 360 System – N Antiserum to Human Plasminogen Assay – Product Description 156

Atellica COAG 360 System – Protein S Ac Assay – Product Status 156

Atellica COAG 360 System – Protein S Ac Assay – Product Description 157

Atellica COAG 360 System – Ristocetin Reagent – Product Status 157

Atellica COAG 360 System – Ristocetin Reagent – Product Description 157

Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 158

ADVIA 120 Hematology System – IRF Test – Product Status 158

ADVIA 120 Hematology System – IRF Test – Product Description 159

ADVIA 120 Hematology System – MPC Test – Product Status 159

ADVIA 120 Hematology System – MPC Test – Product Description 159

ADVIA 120 Hematology System – MPM Test – Product Status 159

ADVIA 120 Hematology System – MPM Test – Product Description 160

ADVIA 2120 Hematology System – MPC Test – Product Status 160

ADVIA 2120 Hematology System – MPC Test – Product Description 160

ADVIA 2120 Hematology System – MPM Test – Product Status 161

ADVIA 2120 Hematology System – MPM Test – Product Description 161

ADVIA 2120i Hematology System – MPC Test – Product Status 161

ADVIA 2120i Hematology System – MPC Test – Product Description 162

ADVIA 2120i Hematology System – MPM Test – Product Status 162

ADVIA 2120i Hematology System – MPM Test – Product Description 162

ADVIA Centaur XP Immunoassay System – D-Dimer Assay – Product Status 163

ADVIA Centaur XP Immunoassay System – D-Dimer Assay – Product Description 163

Sysmex CS-2000i System – Multifibren U Assay – Product Status 163

Sysmex CS-2000i System – Multifibren U Assay – Product Description 164

Sysmex CS-2100i System – Multifibren U Assay – Product Status 164

Sysmex CS-2100i System – Multifibren U Assay – Product Description 164

Sysmex CS-2500 System – Von Willebrand Factor Test – Product Status 165

Sysmex CS-2500 System – Von Willebrand Factor Test – Product Description 165

Sysmex CS-5100 System – Von Willebrand Factor Assay – Product Status 165

Sysmex CS-5100 System – Von Willebrand Factor Assay – Product Description 166

Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 167

IMMULITE 1000 System – D-Dimer Assay – Product Status 167

IMMULITE 1000 System – D-Dimer Assay – Product Description 168

IMMULITE 1000 System – Turbo D-Dimer Assay – Product Status 168

IMMULITE 1000 System – Turbo D-Dimer Assay – Product Description 168

Sysmex CA-1500 – Innovance VWF Activity Assay – Product Status 168

Sysmex CA-1500 – Innovance VWF Activity Assay – Product Description 169

Sysmex CA-1500 – PT Multicalibrators Assay – Product Status 169

Sysmex CA-1500 – PT Multicalibrators Assay – Product Description 169

Sysmex CA-530 – PT Multicalibrators Assay – Product Status 170

Sysmex CA-530 – PT Multicalibrators Assay – Product Description 170

Sysmex CA-560 – Innovance VWF Activity Assay – Product Status 170

Sysmex CA-560 – Innovance VWF Activity Assay – Product Description 171

Sysmex CA-560 – PT Multicalibrators Assay – Product Status 171

Sysmex CA-560 – PT Multicalibrators Assay – Product Description 171

Sysmex CA-7000 – Innovance VWF Activity Assay – Product Status 172

Sysmex CA-7000 – Innovance VWF Activity Assay – Product Description 172

Sysmex CA-7000 – PT Multicalibrators Assay – Product Status 172

Sysmex CA-7000 – PT Multicalibrators Assay – Product Description 173

Silver Lake Research Corporation Pipeline Products & Ongoing Clinical Trials Overview 174

HemoTypeBT – Product Status 174

HemoTypeBT – Product Description 174

SonoMedix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 175

NanoAcoustic Blood Analyzer – Product Status 175

NanoAcoustic Blood Analyzer – Product Description 175

SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 176

D-Dimer Assay – Product Status 176

D-Dimer Assay – Product Description 176

SpinChip – APTT Assay – Product Status 177

SpinChip – APTT Assay – Product Description 177

SpinChip – PT Assay – Product Status 177

SpinChip – PT Assay – Product Description 178

SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 179

IgXPlex – HIT Assay – Product Status 179

IgXPlex – HIT Assay – Product Description 179

Stichting Lygature Pipeline Products & Ongoing Clinical Trials Overview 180

Acute Marker Assay – Product Status 180

Acute Marker Assay – Product Description 180

Blood Capacity Assay – Product Status 181

Blood Capacity Assay – Product Description 181

T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 182

T2HemoStat – Product Status 182

T2HemoStat – Product Description 182

T2MR Assay – Platelet Function Testing – Product Status 183

T2MR Assay – Platelet Function Testing – Product Description 183

The Binding Site Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 184

Optilite – Fibrinogen Assay – Product Status 184

Optilite – Fibrinogen Assay – Product Description 184

ThromboTherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 185

tPA-Challenge Assay – Product Status 185

tPA-Challenge Assay – Product Description 185

Tosoh Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 186

AIA-1800 – D-dimer Test – Product Status 186

AIA-1800 – D-dimer Test – Product Description 186

AIA-600 II – D-dimer Test – Product Status 187

AIA-600 II – D-dimer Test – Product Description 187

Transfusion & Transplantation Technologies (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 188

Aegis – DIC Assay – Product Status 188

Aegis – DIC Assay – Product Description 188

Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 189

Diagnostic Assay – Coagulation – Product Status 189

Diagnostic Assay – Coagulation – Product Description 189

Handheld POC Coagulation Testing System – Ambulatory Care – Product Status 190

Handheld POC Coagulation Testing System – Ambulatory Care – Product Description 190

Immunoassay Test – D-Dimer – Product Status 190

Immunoassay Test – D-Dimer – Product Description 191

Xprecia Prime – Product Status 191

Xprecia Prime – Product Description 191

University of Burdwan Pipeline Products & Ongoing Clinical Trials Overview 192

Hemoglobinopathy- Thalassemia Carrier Screening Kit – Product Status 192

Hemoglobinopathy- Thalassemia Carrier Screening Kit – Product Description 192

University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 193

Diagnostic Tool – Blood Coagulation – Product Status 193

Diagnostic Tool – Blood Coagulation – Product Description 193

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 194

Thrombelastography Assay – Product Status 194

Thrombelastography Assay – Product Description 194

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 195

Hemoglobin Measurement Device – Product Status 195

Hemoglobin Measurement Device – Product Description 195

University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 196

Thrombin Generation Assay – Product Status 196

Thrombin Generation Assay – Product Description 196

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 197

mHemoRetractoMeter – Product Status 197

mHemoRetractoMeter – Product Description 197

University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 198

MEMS Based Blood Coagulometer – Product Status 198

MEMS Based Blood Coagulometer – Product Description 198

University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 199

Diagnostic Assay – Hemophilia – Product Status 199

Diagnostic Assay – Hemophilia – Product Description 199

University of Washington Pipeline Products & Ongoing Clinical Trials Overview 200

Blood-Clotting Test – Product Status 200

Blood-Clotting Test – Product Description 200

VitaMe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 201

Iron.Scan – Product Status 201

Iron.Scan – Product Description 201

Glossary 290

Figures

Hematological Disorders – Pipeline Products by Stage of Development 20_x000D_

Hematological Disorders – Pipeline Products by Segment 21_x000D_

Hematological Disorders – Pipeline Products by Territory 23_x000D_

Hematological Disorders – Pipeline Products by Regulatory Path 24_x000D_

Hematological Disorders – Pipeline Products by Estimated Approval Date 25_x000D_

Hematological Disorders – Ongoing Clinical Trials 26_x000D_

Frequently asked questions

Hematological Disorders Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies standard reports
Currency USD
$4,000

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