|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