ECG Monitoring Equipment Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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ECG Monitoring Equipment Pipeline Market Report Overview

Electrocardiogram (ECG) monitoring equipment records electrocardiogram (ECG) and is used to evaluate 10 seconds (or a specific time interval) of electrical activity of the heart so a physician can determine the condition of a patient’s heart.

The ECG monitoring equipment 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 Territories ·       The US

·       Europe

·       China

·       Israel

·       Japan

Key Regulatory Paths ·       510(k)

·       CE

·       NMPA

·       Ninsho

·       UKCA

·       ICAC

Leading Companies ·       Advanced Medical Electronics Corp,

·       Agatsa Software Pvt Ltd,

·       Arizona State University,

·       Auscultech Dx,

·       Ben-Gurion University of the Negev

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ECG Monitoring Equipment Pipeline Market Segmentation by Territories

A few of the key territories with the ECG monitoring equipment pipeline market are the US, Europe, China, Israel, and Japan. As of September 2024, the US accounted for the highest number of pipeline products.

ECG Monitoring Equipment Pipeline Market Analysis by Territories, 2024 (%)

ECG Monitoring Equipment Pipeline Market Analysis by Territories, 2024 (%)

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ECG Monitoring Equipment Pipeline Market Segmentation by Regulatory Paths

The key regulatory paths in the ECG monitoring equipment pipeline products market are 510(k), CE, NMPA, Ninsho, UKCA, and ICAC. As of September 2024, 510(k) was the most followed pathway for pipeline products in the ECG monitoring equipment market.

ECG Monitoring Equipment Pipeline Market Analysis by Regulatory Paths, 2024 (%)

ECG Monitoring Equipment Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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ECG Monitoring Equipment Pipeline Market – Competitive Landscape

A few of the key companies associated with the ECG monitoring equipment pipeline market are Advanced Medical Electronics Corp, Agatsa Software Pvt Ltd, Arizona State University, Auscultech Dx, and Ben-Gurion University of the Negev, among others.

Advanced Medical Electronics Corp (AME): Headquartered in Maple Grove, Minnesota, the US, it is a medical device company that provides research and development services. The company’s products include original equipment manufacturer (OEM) devices, battery-powered surgical headlamps, wrist-worn pulse oximeters, and others. It also offers systems design, embedded design, electronics and instrumentation design, wireless design, software development, system testing, and prototype building, among others.

Agatsa Software Pvt Ltd (Agatsa): Headquartered in Noida, Uttar Pradesh, India, it provides health monitoring devices and applications to improve the health of individuals. It offers a pocket-sized ECG monitor and mobile app to track, interpret, and record ECG data, enabling users to share their data with doctors and take preventive action. The company caters its solutions to heart patients, fitness firms, doctors, and institutions.

ECG Monitoring Equipment Pipeline Market Analysis by Companies, 2024

ECG Monitoring Equipment Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

ECG Monitoring Equipment Pipeline Market Territories Outlook (2024)

  • The US
  • Europe
  • China
  • Israel
  • Japan

ECG Monitoring Equipment Pipeline Market Regulatory Paths Outlook (2024)

  • 510(k)
  • CE
  • NMPA
  • Ninsho
  • UKCA
  • ICAC

Scope

This report provides:

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

Reasons to Buy

  • 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 ECG monitoring equipment 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 an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Advanced Medical Electronics Corp
Agatsa Software Pvt Ltd
Arizona State University
Auscultech Dx
Ben-Gurion University of the Negev
BioSense
Biotricity Inc
Cambridge Heartwear Ltd
Carditek Medical Devices Pvt Ltd
Cirtec Medical Corp
Cognionics, Inc.
Coland Holdings Limited
Cybernet Medical
EasyCardioGram
EasyG LLC
Endotronix Inc
Global Instrumentation LLC
Heart Health, Inc.
Heart Test Laboratories Inc
Heart Tronics, Inc. (Inactive)
HeartBeam Inc
IMEXCO General Ltd
Imperial College London
iRhythm Technologies Inc
Johns Hopkins University
K2 Medical Ltd
LifeWatch Technologies, Ltd.
LivaNova PLC
Mayo Clinic
Medical Care Technologies, Inc.
Medi-Lynx Cardiac Monitoring LLC
MicroPort Scientific Corp
Minnesota Health Solutions Corporation
MiRTLE Medical LLC
MobilECG Laboratories Ltd.
NewCardio Inc
Nihon Kohden Corp
NimbleHeart Inc.
Novosense AB
Orbital Research Inc.
Peacs BV
Polytechnic University of Catalonia
Preventice Inc
Quantum Innovations
Rapid Rhythm Ltd
Stanford University
The Lundquist Institute
Toumaz Technology Limited
Trivitron Healthcare Pvt Ltd
Universitas Padjadjaran
University College London
University of Michigan
University of Michigan Pediatric Device Consortium
University of Sydney
University of Tampere
ZBeats Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 8

|1.2 List of Figures 12

2 Introduction 13

2.1 ECG Monitoring Equipment Overview 13

3 Products under Development 14

3.1 ECG Monitoring Equipment – Pipeline Products by Stage of Development 14

3.2 ECG Monitoring Equipment – Pipeline Products by Territory 15

3.3 ECG Monitoring Equipment – Pipeline Products by Regulatory Path 16

3.4 ECG Monitoring Equipment – Pipeline Products by Estimated Approval Date 17

3.5 ECG Monitoring Equipment – Ongoing Clinical Trials 18

4 ECG Monitoring Equipment – Pipeline Products under Development by Companies 19

4.1 ECG Monitoring Equipment Companies – Pipeline Products by Stage of Development 19

4.2 ECG Monitoring Equipment – Pipeline Products by Stage of Development 22

5 ECG Monitoring Equipment Companies and Product Overview 24

5.1 Advanced Medical Electronics Corp Company Overview 24

5.1.1 Advanced Medical Electronics Corp Pipeline Products & Ongoing Clinical Trials Overview 24

5.2 Agatsa Software Pvt Ltd Company Overview 25

5.2.1 Agatsa Software Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Arizona State University Company Overview 27

5.3.1 Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Auscultech Dx Company Overview 28

5.4.1 Auscultech Dx Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Ben-Gurion University of the Negev Company Overview 29

5.5.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 BioSense Company Overview 30

5.6.1 BioSense Pipeline Products & Ongoing Clinical Trials Overview 30

5.7 Biotricity Inc Company Overview 31

5.7.1 Biotricity Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.8 Cambridge Heartwear Ltd Company Overview 32

5.8.1 Cambridge Heartwear Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.9 Carditek Medical Devices Pvt Ltd Company Overview 33

5.9.1 Carditek Medical Devices Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.10 Cirtec Medical Corp Company Overview 34

5.10.1 Cirtec Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 34

5.11 Cognionics, Inc. Company Overview 35

5.11.1 Cognionics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

5.12 Coland Holdings Limited Company Overview 36

5.12.1 Coland Holdings Limited Pipeline Products & Ongoing Clinical Trials Overview 36

5.13 Cybernet Medical Company Overview 37

5.13.1 Cybernet Medical Pipeline Products & Ongoing Clinical Trials Overview 37

5.14 EasyCardioGram Company Overview 38

5.14.1 EasyCardioGram Pipeline Products & Ongoing Clinical Trials Overview 38

5.15 EasyG LLC Company Overview 39

5.15.1 EasyG LLC Pipeline Products & Ongoing Clinical Trials Overview 39

5.16 Endotronix Inc Company Overview 40

5.16.1 Endotronix Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.17 Global Instrumentation LLC Company Overview 41

5.17.1 Global Instrumentation LLC Pipeline Products & Ongoing Clinical Trials Overview 41

5.18 Heart Health, Inc. Company Overview 42

5.18.1 Heart Health, Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

5.19 Heart Test Laboratories Inc Company Overview 43

5.19.1 Heart Test Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.20 Heart Tronics, Inc. (Inactive) Company Overview 46

5.20.1 Heart Tronics, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 46

5.21 HeartBeam Inc Company Overview 47

5.21.1 HeartBeam Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.22 IMEXCO General Ltd Company Overview 48

5.22.1 IMEXCO General Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.23 Imperial College London Company Overview 49

5.23.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 49

5.24 iRhythm Technologies Inc Company Overview 50

5.24.1 iRhythm Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.25 Johns Hopkins University Company Overview 53

5.25.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 53

5.26 K2 Medical Ltd Company Overview 54

5.26.1 K2 Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

5.27 LifeWatch Technologies, Ltd. Company Overview 57

5.27.1 LifeWatch Technologies, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57

5.28 LivaNova PLC Company Overview 58

5.28.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 58

5.29 Mayo Clinic Company Overview 59

5.29.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 59

5.30 Medical Care Technologies, Inc. Company Overview 60

5.30.1 Medical Care Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

5.31 Medi-Lynx Cardiac Monitoring LLC Company Overview 61

5.31.1 Medi-Lynx Cardiac Monitoring LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.32 MicroPort Scientific Corp Company Overview 64

5.32.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 64

5.33 Minnesota Health Solutions Corporation Company Overview 66

5.33.1 Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

5.34 MiRTLE Medical LLC Company Overview 67

5.34.1 MiRTLE Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.35 MobilECG Laboratories Ltd. Company Overview 70

5.35.1 MobilECG Laboratories Ltd. Pipeline Products & Ongoing Clinical Trials Overview 70

5.36 NewCardio Inc Company Overview 71

5.36.1 NewCardio Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.37 Nihon Kohden Corp Company Overview 73

5.37.1 Nihon Kohden Corp Pipeline Products & Ongoing Clinical Trials Overview 73

5.38 NimbleHeart Inc. Company Overview 75

5.38.1 NimbleHeart Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

5.39 Novosense AB Company Overview 76

5.39.1 Novosense AB Pipeline Products & Ongoing Clinical Trials Overview 76

5.40 Orbital Research Inc. Company Overview 77

5.40.1 Orbital Research Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

5.41 Peacs BV Company Overview 78

5.41.1 Peacs BV Pipeline Products & Ongoing Clinical Trials Overview 78

5.42 Polytechnic University of Catalonia Company Overview 79

5.42.1 Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 79

5.43 Preventice Inc Company Overview 82

5.43.1 Preventice Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.44 Quantum Innovations Company Overview 85

5.44.1 Quantum Innovations Pipeline Products & Ongoing Clinical Trials Overview 85

5.45 Rapid Rhythm Ltd Company Overview 86

5.45.1 Rapid Rhythm Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.46 Stanford University Company Overview 87

5.46.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 87

5.47 The Lundquist Institute Company Overview 88

5.47.1 The Lundquist Institute Pipeline Products & Ongoing Clinical Trials Overview 88

5.48 Toumaz Technology Limited Company Overview 89

5.48.1 Toumaz Technology Limited Pipeline Products & Ongoing Clinical Trials Overview 89

5.49 Trivitron Healthcare Pvt Ltd Company Overview 90

5.49.1 Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.50 Universitas Padjadjaran Company Overview 91

5.50.1 Universitas Padjadjaran Pipeline Products & Ongoing Clinical Trials Overview 91

5.51 University College London Company Overview 92

5.51.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 92

5.52 University of Michigan Company Overview 93

5.52.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 93

5.53 University of Michigan Pediatric Device Consortium Company Overview 94

5.53.1 University of Michigan Pediatric Device Consortium Pipeline Products & Ongoing Clinical Trials Overview 94

5.54 University of Sydney Company Overview 95

5.54.1 University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 95

5.55 University of Tampere Company Overview 96

5.55.1 University of Tampere Pipeline Products & Ongoing Clinical Trials Overview 96

5.56 ZBeats Inc Company Overview 97

5.56.1 ZBeats Inc Pipeline Products & Ongoing Clinical Trials Overview 97

6 ECG Monitoring Equipment- Recent Developments 100

6.1 Sep 11, 2024: iRhythm Technologies Announces Japanese Regulatory Approval of the Zio ECG Monitoring System, the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence 100

6.2 Sep 09, 2024: iRhythm Unveils Data Demonstrating Superior Real-World Performance of Next-Generation Zio Monitor at HRX 2024 Meeting 100

6.3 Sep 01, 2024: iRhythm Technologies Announces Results of GUARD-AF Trial 102

6.4 Aug 27, 2024: Medtronic Chairman and CEO Geoff Martha to Speak at the Wells Fargo Healthcare Conference 103

6.5 Aug 27, 2024: Medtronic Chairman and CEO Geoff Martha to Speak at the Wells Fargo Healthcare Conference 103

6.6 Aug 14, 2024: Cardinal Health Reports Fourth Quarter and Fiscal Year 2024 Results and Raises Fiscal Year 2025 Guidance 103

6.7 Aug 06, 2024: Leading Cardiac Diagnostics Innovator Zywie Announces Industry Partnership With MedAxiom 105

6.8 Aug 02, 2024: Nihon Kohden Announces Consolidated Financial Results for the 1st Quarter of the Fiscal Year Ending March 31, 2025 105

6.9 Aug 01, 2024: iRhythm Technologies Chief Financial Officer to Step Down on August 31, 2024 106

6.10 Jul 26, 2024: Innovation Value Institute Analysis Demonstrates Heartsciences’ Myovista Wavecg Potential to Improve Cardiovascular Pathway Efficiency 106

6.11 Jul 25, 2024: HeartSciences Selected to Demonstrate MyoVista wavECG at the United Nations General Assembly Digital Health Symposium as a Technology to Radically Transform Healthcare 107

6.12 Jul 17, 2024: AliveCor’s Kardia 12L ECG System Receives Category III CPT Codes 107

6.13 Jul 10, 2024: AliveCor launches InstantQT in Europe for ECG evaluations 108

6.14 Jul 08, 2024: CONMED to Announce Second Quarter 2024 Financial Results on July 31, 2024 108

6.15 Jun 25, 2024: AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System 108

6.16 Jun 20, 2024: New, Simple Test Detects Rare Fatal Genetic Heart Condition 109

6.17 Jun 19, 2024: AliveCor Receives 510(K) Clearance For Impala 110

6.18 Jun 19, 2024: Shenzhen Le Medical Technology Receives 510(K) Clearance For Electrocardiograph Model: ECG301 110

6.19 Jun 13, 2024: eReserchTechnology Receives 510(K) Clearance For CardioSphere 110

6.20 Jun 13, 2024: Medtronic Confirms Global Layoffs 111

6.21 Jun 05, 2024: AliveCor’s AI-backed ECG Offerings Featured in New Film Series on Innovative Technologies Presented by the Consumer Technology Association 111

6.22 Jun 05, 2024: ACSD Granted Significant Telemedicine Patent 111

6.23 May 27, 2024: Cardiomatics Partners With Biotronik In Germany To Expand Market Access Of Its Advanced Ai-powered ECG Analysis Solution 112

6.24 May 20, 2024: HeartSciences Announces Further Internationalization of its AI-ECG Patent Portfolio 112

6.25 May 14, 2024: InfoBionic.Ai Announces Next-Generation Advancements in the MoMe ARC Suite of Products 113

6.26 Apr 24, 2024: HeartSciences Announces Grant of Fundamental Patent by the European Patent Office Covering Assessment of Diastolic Function of the Heart Using AI-ECG 114

6.27 Apr 23, 2024: Rett Syndrome Research Trust Partners with Vivalink to Shift Symptom Assessment Paradigms in Rett Syndrome 114

6.28 Apr 15, 2024: Inmode Responds to Btl Petition for Inter Partes Review of Patent Inmode Is Asserting against Btl 115

6.29 Apr 05, 2024: SHL Telemedicine: Invitation to Conference Call Presenting Annual Results 2023 115

6.30 Apr 02, 2024: Peerbridge Health’s Remote Device for Early Detection of Heart Failure Achieves

95.7% Success Rate in Trial 116

6.31 Mar 26, 2024: HeartSciences Announces Podium Presentation at World Congress of Anesthesiologists on the Utility of MyoVista Wavelet ECG For Detection of Left Ventricular Diastolic Dysfunction in Preoperative Patients 116

6.32 Mar 12, 2024: HeartSciences’ Announces Peer-Reviewed Publication Evaluating Use of MyoVista Technology to Detect Asymptomatic Left Ventricular Dysfunction in Patients with Type 2 Diabetes 117

6.33 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 118

6.34 Mar 08, 2024: Wellysis and Artella Solutions Launch Innovative Remote Cardiac Monitoring Service in the US. 118

6.35 Mar 06, 2024: Heartsciences Announces Canada Patent Grant Covering Myovista Wavelet Technology 118

6.36 Mar 04, 2024: Enhanced Design Breakthrough Makes Ventripoint’s VMS+ Even Simpler to Use 119

6.37 Feb 28, 2024: Bob Azelby to Join Cardinal Health Board of Directors 119

6.38 Feb 22, 2024: Wellysis Receives Additional 510(K) Clearance for S-Patch Ex Wearable ECG Patch 120

6.39 Feb 20, 2024: Philips Delivers Strong ESG Performance in 2023 120

6.40 Feb 14, 2024: GE HealthCare Management to Present at Upcoming Investor Conferences 121

6.41 Feb 13, 2024: PCA 500– The World’s Most Efficient and Versatile 12-Lead ECG, Receives FDA Clearance for Use in Acute Care 122

6.42 Feb 12, 2024: Bittium Expands Its Range of Supported ECG Analysis Software by Collaborating With a Service Partner 122

6.43 Feb 07, 2024: Delve Health and AliveCor Collaborate to Revolutionize Digital Healthcare Solutions in Cardiology 123

6.44 Feb 01, 2024: Imperial College London TELE-ACS Clinical Trial Results, Using SHL Telemedicine’s SmartHeart Technology, to Be Presented at ACC 24 124

6.45 Feb 01, 2024: New 4D Imaging May Detect Poor Pumping in Deadly Heart Disease 124

6.46 Jan 24, 2024: Wellysis Goes Global with ECG Monitor ‘S-Patch’, Enters US and Indian Markets 125

6.47 Jan 18, 2024: GE HealthCare to Announce Fourth Quarter and Full Year 2023 Results on February 6, 2024 126

6.48 Jan 16, 2024: Research Shows How a Tiny Device in the Ear Canal Can Monitor Heart Health 126

6.49 Jan 16, 2024: Research Shows How a Tiny Device in the Ear Canal Can Monitor Heart Health 127

6.50 Jan 05, 2024: Largest Ever Real-World Evidence Study of Ambulatory Cardiac Monitoring Demonstrates Clinical Superiority of iRhythm’s Zio Long-Term Continuous Monitoring Service 128

6.51 Jan 04, 2024: AI-Driven Study Redefines Right Heart Health Assessment With Novel Predictive Model 129

6.52 Jan 03, 2024: iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio monitor and ZEUS System 130

6.53 Dec 26, 2023: Bionet Receives 510(k) Clearance for Cardio Q50 Electrocardiograph 131

6.54 Dec 21, 2023: QT Medical Receives 510(K) Clearance For QT ECG System 131

6.55 Dec 18, 2023: Heart Vest Could Help Predict Sudden Cardiac Death Risk 131

6.56 Dec 13, 2023: Lucem Health Introduces Reveal for Stroke to Accelerate Treatment of AFib-Related Stroke Risks 132

6.57 Dec 06, 2023: Trismed Receives 510(K) Clearance For CARDIPIA 800H ECG System 133

6.58 Dec 05, 2023: HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway 133

6.59 Nov 27, 2023: SHL Telemedicine launches SmartHeart membership in US 134

6.60 Nov 22, 2023: BardyDx Receives Additional 510(K) Clearance For Carnation Ambulatory Monitor 134

6.61 Nov 17, 2023: Ambu Notice for the Annual General Meeting 135

6.62 Nov 15, 2023: Advanced Brain Monitoring, announces integration of its mobile, wireless 24-channel EEG system with the Stratus EEG™ cloud-based software for seizure and epilepsy monitoring 135

6.63 Nov 13, 2023: HeartSciences’ MyoVista wavECGTM Selected for Heart Screening of Irish Garda National Police Officers 136

6.64 Nov 09, 2023: AccurKardia Delivers Its ECG Interpretation Software Within the Lucem Health Reveal Family of Clinical AI Solutions 136

6.65 Nov 06, 2023: SHL Telemedicine Establishes US Nationwide Cardiology Network for ECG Interpretations and Telehealth Visits 137

6.66 Nov 06, 2023: AI Stethoscope Rolled out to 100 GP Clinics to Help Diagnose Heart Failure 137

6.67 Nov 03, 2023: Cardinal Health Reports First Quarter Fiscal 2024 Results and Raises Fiscal 2024 Outlook 139

6.68 Nov 02, 2023: Draeger Medical Receives Additional 510(k) Clearance for Infinity M300 ECG Wearable Device 140

6.69 Oct 31, 2023: Draeger Medical Receives 510(K) Clearance For Infinity M300+ 140

6.70 Oct 31, 2023: CONMED Corp. to Participate in Fireside Chats at Two Investor Conferences on November 14-15 140

6.71 Oct 25, 2023: Flex Reports Second Quarter Fiscal 2024 Results; Announces Plan to Spin-Off Remaining Interest in Nextracker to Flex Shareholders 141

6.72 Oct 23, 2023: SHL Telemedicine Announces Advancements in its Direct-to-Consumer Strategy in the US 142

6.73 Oct 13, 2023: InfoBionic Secures FDA 510(k) Clearance For MoMe ARC 143

6.74 Oct 12, 2023: Ventripoint AI Heart Imaging Technology To Be Presented at British Society of Echocardiography Annual Conference 144

6.75 Oct 10, 2023: Infobionic Receives FDA 510(K) Clearance for Its Next Generation MoMe ARC Solution 144

6.76 Sep 26, 2023: SHL Telemedicine’s SmartHeart Technology Shows Remarkable Effects in Mayo Clinic and Imperial College London Trials 145

6.77 Sep 26, 2023: AliveCor’s KardiaMobile 6L Becomes First Personal ECG Device Recommended for Use in Psychiatric Services in England and Wales 145

7 Appendix 147

7.1 Methodology 147

7.2 About GlobalData 150

7.3 Contact Us 150

7.4 Disclaimer 150

Table

ECG Monitoring Equipment – Pipeline Products by Stage of Development 14

ECG Monitoring Equipment – Pipeline Products by Territory 15

ECG Monitoring Equipment – Pipeline Products by Regulatory Path 16

ECG Monitoring Equipment – Pipeline Products by Estimated Approval Date 17

ECG Monitoring Equipment – Ongoing Clinical Trials 18

ECG Monitoring Equipment Companies – Pipeline Products by Stage of Development 19

ECG Monitoring Equipment – Pipeline Products by Stage of Development 22

Advanced Medical Electronics Corp Pipeline Products & Ongoing Clinical Trials Overview 24

Ultra Low Power Wireless Electrocardiograph Sensor – Product Status 24

Ultra Low Power Wireless Electrocardiograph Sensor – Product Description 24

Agatsa Software Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

SanketLife 1.0 – Product Status 25

SanketLife 1.0 – Product Description 25

SanketLife 2.0 – Product Status 26

SanketLife 2.0 – Product Description 26

Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 27

GeM-REM Enabled ECG Sensor – Product Status 27

GeM-REM Enabled ECG Sensor – Product Description 27

Auscultech Dx Pipeline Products & Ongoing Clinical Trials Overview 28

Beat-To-Beat Fetal ECG System – Product Status 28

Beat-To-Beat Fetal ECG System – Product Description 28

Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 29

P-Wave Detection Device – Product Status 29

P-Wave Detection Device – Product Description 29

BioSense Pipeline Products & Ongoing Clinical Trials Overview 30

BioSense System – Product Status 30

BioSense System – Product Description 30

Biotricity Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Bioflux 2.0 – Product Status 31

Bioflux 2.0 – Product Description 31

Cambridge Heartwear Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Heartsense – Product Status 32

Heartsense – Product Description 32

Carditek Medical Devices Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Sydantek – Product Status 33

Sydantek – Product Description 33

Cirtec Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 34

Electrocardiograph – Product Status 34

Electrocardiograph – Product Description 34

Cognionics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

ECG Sensor – Product Status 35

ECG Sensor – Product Description 35

Coland Holdings Limited Pipeline Products & Ongoing Clinical Trials Overview 36

ECG Monitoring Device – Product Status 36

ECG Monitoring Device – Product Description 36

Cybernet Medical Pipeline Products & Ongoing Clinical Trials Overview 37

Wireless ECG Device – Product Status 37

Wireless ECG Device – Product Description 37

EasyCardioGram Pipeline Products & Ongoing Clinical Trials Overview 38

EasyCardioGram – Product Status 38

EasyCardioGram – Product Description 38

EasyG LLC Pipeline Products & Ongoing Clinical Trials Overview 39

EasyG – Product Status 39

EasyG – Product Description 39

Endotronix Inc Pipeline Products & Ongoing Clinical Trials Overview 40

ECG Reader – Product Status 40

ECG Reader – Product Description 40

Global Instrumentation LLC Pipeline Products & Ongoing Clinical Trials Overview 41

Cardio-Mat – Product Status 41

Cardio-Mat – Product Description 41

Heart Health, Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

Heart Health Monitor – Product Status 42

Heart Health Monitor – Product Description 42

Heart Test Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 43

MyoVista Wavelet ECG Cardiac Testing Device – Product Status 43

MyoVista Wavelet ECG Cardiac Testing Device – Product Description 43

Heart Test Laboratories Inc – Ongoing Clinical Trials Overview 44

MyoVista Wavelet ECG Cardiac Testing Device – Comparing Myovista wavECG to NT Pro-BNP for Heart Failure Referral 45

MyoVista Wavelet ECG Cardiac Testing Device – MyoVista wavECG Clinical Evaluation: >=60 y/o Enrichment Population 45

MyoVista Wavelet ECG Cardiac Testing Device – MyoVista wavECG Clinical Validation Study 45

Heart Tronics, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 46

Cardiac Vest – Product Status 46

Cardiac Vest – Product Description 46

HeartBeam Inc Pipeline Products & Ongoing Clinical Trials Overview 47

iCardiologist – Product Status 47

iCardiologist – Product Description 47

IMEXCO General Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

CardioScope – Product Status 48

CardioScope – Product Description 48

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 49

Single Ear-ECG Device – Product Status 49

Single Ear-ECG Device – Product Description 49

iRhythm Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Zio XT Patch – Product Status 50

Zio XT Patch – Product Description 50

iRhythm Technologies Inc – Ongoing Clinical Trials Overview 51

Zio XT Patch – A Multi-centre Cohort Study Comparing Health Outcome Data From Holter Monitoring to 14 Day Zio Monitoring in People Where Ambulatory ECG Monitoring is Required 52

Zio XT Patch – The Heart Rhythm Twins Study — A Pilot Study in Identical and Fraternal Twins 52

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 53

Cell Phone EKG Device – Product Status 53

Cell Phone EKG Device – Product Description 53

K2 Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Cara Conduction Disturbance Monitor 2.0 – Product Status 54

Cara Conduction Disturbance Monitor 2.0 – Product Description 54

K2 Medical Ltd – Ongoing Clinical Trials Overview 55

Cara Conduction Disturbance Monitor 2.0 – A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS). 56

Cara Conduction Disturbance Monitor 2.0 – Intra-procedural ECG Changes During TAVR 56

LifeWatch Technologies, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57

FeatherLite – Product Status 57

FeatherLite – Product Description 57

LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 58

Spiderflash AFIB – Product Status 58

Spiderflash AFIB – Product Description 58

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 59

POC AI-ECG – COVID-19 – Product Status 59

POC AI-ECG – COVID-19 – Product Description 59

Medical Care Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

Tele-Health Suite – Heart Vital Signs – Product Status 60

Tele-Health Suite – Heart Vital Signs – Product Description 60

Medi-Lynx Cardiac Monitoring LLC Pipeline Products & Ongoing Clinical Trials Overview 61

PocketECG CRS – Home – Product Status 61

PocketECG CRS – Home – Product Description 61

Medi-Lynx Cardiac Monitoring LLC – Ongoing Clinical Trials Overview 62

PocketECG CRS – Home – Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG 63

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 64

ECG Monitor – Product Status 64

ECG Monitor – Product Description 64

Implantable Cardiac Monitor (MRI ICM) – Product Status 65

Implantable Cardiac Monitor (MRI ICM) – Product Description 65

Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

QTc Meter – Product Status 66

QTc Meter – Product Description 66

MiRTLE Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 67

12-Lead ECG Monitoring Device – Product Status 67

12-Lead ECG Monitoring Device – Product Description 67

MiRTLE Medical LLC – Ongoing Clinical Trials Overview 68

12-Lead ECG Monitoring Device – Evaluation of MRI-conditional 12-lead ECG 69

MobilECG Laboratories Ltd. Pipeline Products & Ongoing Clinical Trials Overview 70

MobilECG – Product Status 70

MobilECG – Product Description 70

NewCardio Inc Pipeline Products & Ongoing Clinical Trials Overview 71

CardioBip – Atrial Fibrillation – Product Status 71

CardioBip – Atrial Fibrillation – Product Description 71

CardioBip – Cardiac Rhythm Remote Monitoring – Product Status 72

CardioBip – Cardiac Rhythm Remote Monitoring – Product Description 72

Nihon Kohden Corp Pipeline Products & Ongoing Clinical Trials Overview 73

HeartMate – Product Status 73

HeartMate – Product Description 73

RADARCIRC – Product Status 74

RADARCIRC – Product Description 74

NimbleHeart Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

Physiotrace Snap – Product Status 75

Physiotrace Snap – Product Description 75

Novosense AB Pipeline Products & Ongoing Clinical Trials Overview 76

CardioSense System – Product Status 76

CardioSense System – Product Description 76

Orbital Research Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

CardioWare Harness – Product Status 77

CardioWare Harness – Product Description 77

Peacs BV Pipeline Products & Ongoing Clinical Trials Overview 78

ECG Excellence – Product Status 78

ECG Excellence – Product Description 78

Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 79

Footpad ECG Electrode – Product Status 79

Footpad ECG Electrode – Product Description 79

Hand-Held Patient Interface Device – Product Status 80

Hand-Held Patient Interface Device – Product Description 80

Mobile ECG System – Product Status 80

Mobile ECG System – Product Description 81

Multi-Lead ECG System – Product Status 81

Multi-Lead ECG System – Product Description 81

Preventice Inc Pipeline Products & Ongoing Clinical Trials Overview 82

AECG System (Ambulatory External Electrocardiography) – Product Status 82

AECG System (Ambulatory External Electrocardiography) – Product Description 82

Preventice Inc – Ongoing Clinical Trials Overview 83

AECG System (Ambulatory External Electrocardiography) – Tulane iPredict, Prevent (TiPP) Study 84

Quantum Innovations Pipeline Products & Ongoing Clinical Trials Overview 85

Heart Sense – Product Status 85

Heart Sense – Product Description 85

Rapid Rhythm Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Rapid Rhythm ECG System – Product Status 86

Rapid Rhythm ECG System – Product Description 86

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 87

Multilead Electrocardiogram Bandage – Product Status 87

Multilead Electrocardiogram Bandage – Product Description 87

The Lundquist Institute Pipeline Products & Ongoing Clinical Trials Overview 88

ECG Lead System – Product Status 88

ECG Lead System – Product Description 88

Toumaz Technology Limited Pipeline Products & Ongoing Clinical Trials Overview 89

ECG And Activity Monitor – Type 2 Diabetes – Product Status 89

ECG And Activity Monitor – Type 2 Diabetes – Product Description 89

Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

Wireless ECG System – Product Status 90

Wireless ECG System – Product Description 90

Universitas Padjadjaran Pipeline Products & Ongoing Clinical Trials Overview 91

Portable Smart Holder ECG – Product Status 91

Portable Smart Holder ECG – Product Description 91

University College London Pipeline Products & Ongoing Clinical Trials Overview 92

Electrocardiographic Imaging (ECGI) Vest – Product Status 92

Electrocardiographic Imaging (ECGI) Vest – Product Description 92

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 93

Brain-Heart Monitoring Device – Product Status 93

Brain-Heart Monitoring Device – Product Description 93

University of Michigan Pediatric Device Consortium Pipeline Products & Ongoing Clinical Trials Overview 94

EKG Placement Device – Product Status 94

EKG Placement Device – Product Description 94

University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 95

Wearable ECG Monitoring System – Product Status 95

Wearable ECG Monitoring System – Product Description 95

University of Tampere Pipeline Products & Ongoing Clinical Trials Overview 96

Implantable ECG Monitoring Device – Product Status 96

Implantable ECG Monitoring Device – Product Description 96

ZBeats Inc Pipeline Products & Ongoing Clinical Trials Overview 97

ZBPro – Product Status 97

ZBPro – Product Description 97

ZBeats Inc – Ongoing Clinical Trials Overview 98

ZBPro – Feasibility Testing of a Novel AI-enabled, Cloud-based ECG Diagnostic Solution to Enable Fast and Affordable Diagnosis in Long-term Continuous Ambulatory ECG Monitoring 99

Glossary 149

Figures

ECG Monitoring Equipment – Pipeline Products by Stage of Development 14

ECG Monitoring Equipment – Pipeline Products by Territory 15

ECG Monitoring Equipment – Pipeline Products by Regulatory Path 16

ECG Monitoring Equipment – Pipeline Products by Estimated Approval Date 17

ECG Monitoring Equipment – Ongoing Clinical Trials 18

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