Continuous Glucose Monitoring Systems-Medical Devices Pipeline Assessment, 2016

Continuous Glucose Monitoring Systems-Medical Devices Pipeline Assessment, 2016


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Executive Summary

Continuous Glucose Monitoring Systems-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Continuous Glucose Monitoring Systems-Medical Devices Pipeline Assessment, 2016" provides an overview of Continuous Glucose Monitoring Systems currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Continuous Glucose Monitoring Systems pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

Extensive coverage of the Continuous Glucose Monitoring Systems under development

The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

The report reviews the major players involved in the development of Continuous Glucose Monitoring Systems and list all their pipeline projects

The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

The report provides key clinical trial data of ongoing trials specific to pipeline products

Recent developments in the segment / industry

Reasons To Buy

The report enables you to-

Formulate significant competitor information, analysis, and insights to improve R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of Continuous Glucose Monitoring Systems under development

Develop market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

In-depth analysis of the product's current stage of development, territory and estimated launch date



Read More



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Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 16

2 Introduction 17

2.1 Continuous Glucose Monitoring Systems Overview 17

3 Products under Development 18

3.1 Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 18

3.2 Continuous Glucose Monitoring Systems-Pipeline Products by Territory 19

3.3 Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 20

3.4 Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 21

3.5 Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 22

4 Continuous Glucose Monitoring Systems-Pipeline Products under Development by Companies 23

4.1 Continuous Glucose Monitoring Systems Companies-Pipeline Products by Stage of Development 23

4.2 Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 27

5 Continuous Glucose Monitoring Systems Companies and Product Overview 31

5.1 A. Menarini Diagnostics S.r.l. Company Overview 31

5.2 Abbott Diabetes Care, Inc. Company Overview 33

5.3 Advanced Biosensors-Ohio, Llc Company Overview 35

5.4 Advanced Medical Electronics Corporation Company Overview 36

5.5 Alcon Inc Company Overview 38

5.6 Arkal Medical, Inc. Company Overview 39

5.7 Azurite Technologies, Inc. Company Overview 41

5.8 Bar-Ilan University Company Overview 42

5.9 Bellco Srl Company Overview 43

5.10 Bio-Impedance General Ltd. Company Overview 44

5.11 Biorasis, Inc. Company Overview 45

5.12 BioTex Inc Company Overview 46

5.13 Biovotion AG Company Overview 47

5.14 Brigham and Women's Hospital Company Overview 49

5.15 CALISTO MEDICAL, INC. (Inactive) Company Overview 50

5.16 Cardiff University Company Overview 51

5.17 CGM3 Ltd Company Overview 52

5.18 ConvaTec Healthcare B Sarl Company Overview 53

5.19 Cyber Medical Ltd. Company Overview 54

5.20 Debiotech SA Company Overview 56

5.21 DexCom Inc Company Overview 58

5.22 DirectSens GmbH Company Overview 70

5.23 Eccrine Systems Inc Company Overview 71

5.24 Echo Therapeutics Inc Company Overview 72

5.25 Ecole Polytechnique Federale de Lausanne Company Overview 76

5.26 eLutions Integrated Systems, Inc. Company Overview 77

5.27 EyeSense GmbH Company Overview 78

5.28 Flowsion A/S Company Overview 82

5.29 Globe Medical Tech Inc Company Overview 84

5.30 GlucoLight Corporation Company Overview 85

5.31 Glucometrics, Inc. Company Overview 86

5.32 Glucometrix AG Company Overview 87

5.33 Glucosense Diagnostics Ltd Company Overview 88

5.34 GlucoSet AS Company Overview 89

5.35 Glucovation Inc Company Overview 90

5.36 GluMetrics Inc Company Overview 91

5.37 Glusense Ltd Company Overview 92

5.38 GlySens Inc Company Overview 93

5.39 GlySure Ltd Company Overview 97

5.40 G-Sense Ltd. Company Overview 100

5.41 Guided Therapeutics Inc Company Overview 101

5.42 Hypo-Safe A/S Company Overview 103

5.43 iGlyko, Inc. Company Overview 106

5.44 Institute of Biomedical Engineering (ISIB-CNR) (Inactive) Company Overview 108

5.45 Insulet Corp Company Overview 109

5.46 Integrity Applications Ltd Company Overview 111

5.47 Invivomon Inc. Company Overview 114

5.48 Invivosense ASA Company Overview 115

5.49 iSense Corporation (Inactive) Company Overview 116

5.50 Luminous Medical Inc Company Overview 117

5.51 Massachusetts Institute of Technology Company Overview 119

5.52 MASTInc Company Overview 120

5.53 Medella Health Inc. Company Overview 121

5.54 Medical Wireless Sensing Ltd Company Overview 122

5.55 Medtronic plc Company Overview 124

5.56 Mellitor Ltd. Company Overview 132

5.57 Microchips Biotech Inc Company Overview 133

5.58 mobiLIFE Company Overview 134

5.59 Nemaura Medical Inc Company Overview 135

5.60 Northwestern University Company Overview 137

5.61 NovioSense B.V. Company Overview 139

5.62 Optiscan Biomedical Corp Company Overview 141

5.63 Pignolo SpA Company Overview 144

5.64 PositiveID Corp Company Overview 145

5.65 Prediktor AS Company Overview 147

5.66 Profusa, Inc. Company Overview 149

5.67 Roche Diagnostics International Ltd Company Overview 150

5.68 San Meditech (Huzhou) Co., Ltd. Company Overview 152

5.69 Senseonics, Incorporated Company Overview 153

5.70 SensiVida Medical Technologies, Inc. (Inactive) Company Overview 156

5.71 Senzime AB Company Overview 157

5.72 Singapore Biomicro Pte Ltd Company Overview 159

5.73 Stanford University Company Overview 160

5.74 Tenax Therapeutics Inc Company Overview 161

5.75 Terumo Corp Company Overview 162

5.76 The Charles Stark Draper Laboratory Inc Company Overview 164

5.77 Ultradian Diagnostics LLC Company Overview 166

5.78 University of Bari Aldo Moro Company Overview 168

5.79 University of Bath Company Overview 169

5.80 University of California Berkeley Company Overview 170

5.81 University of California San Diego Company Overview 172

5.82 University of South Florida Company Overview 174

5.83 University of Strathclyde Company Overview 175

5.84 University of Texas at Arlington Company Overview 176

5.85 Vytrace, Inc. Company Overview 177

5.86 Zyvex Corporation Company Overview 178

6 Continuous Glucose Monitoring Systems- Recent Developments 179

6.1 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 179

6.2 Nov 21, 2016: PositiveID Reports Revenue of $4.6 Million for First Nine Months of 2016, Up 70% from $2.7 Million for First Nine Months of 2015 181

6.3 Nov 18, 2016: Abbott Labs Prices Public Offering of 2.35% Notes due 2019 for USD2.9 Billion 182

6.4 Nov 18, 2016: Abbott Labs Prices Public Offering of 2.9% Notes due 2021 for USD2.85 Billion 182

6.5 Nov 18, 2016: Abbott Labs Prices Public Offering of 3.4% Notes due 2023 for USD1.5 Billion 183

6.6 Nov 18, 2016: Abbott Labs Prices Public Offering of 3.75% Notes due 2026 for USD3 Billion 183

6.7 Nov 18, 2016: Abbott Labs Prices Public Offering of 4.9% Notes due 2046 for USD3.3 Billion 184

6.8 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 184

6.9 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 184

6.10 Nov 14, 2016: Diabetes Management Leader Dexcom Expands Presence in EMEA Markets with new Edinburgh HQ 185

6.11 Nov 11, 2016: Presentation of PRECISE II U.S. Pivotal Trial Data of the Eversense CGM System at the 16th Annual Diabetes Technology Meeting 186

6.12 Nov 11, 2016: GlucoTrack Maker to Present Updated Scientific Data Demonstrating Increased Accuracy 187

6.13 Nov 10, 2016: Tenax Therapeutics Announces Third Quarter 2016 Financial Results and Provides Corporate Update 187

6.14 Nov 07, 2016: GlucoTrack Maker Announces Receipt of Final Regulatory Approval in South Korea 188

6.15 Nov 03, 2016: Insulet Reports Third Quarter 2016 Financial Results 189

6.16 Nov 02, 2016: Henry Schein Reports Record Third Quarter Financial Results 190

6.17 Nov 01, 2016: DexCom Reports Third Quarter 2016 Financial Results 192

6.18 Nov 01, 2016: Tandem Diabetes Care Reports Third Quarter 2016 Financial Results 193

6.19 Oct 27, 2016: Senseonics submits Eversense Continuous Glucose Monitoring system PMA to FDA 194

6.20 Oct 26, 2016: ConvaTec Raises USD1.8 Billion in IPO 195

6.21 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 195

6.22 Oct 24, 2016: NovioSense Raises Funds in Venture Financing 197

6.23 Oct 19, 2016: PositiveID to Present at RedChip's Global Online Growth Conference on October 20th 197

6.24 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 197

6.25 Sep 28, 2016: Abbott Receives FDA Approval for the FreeStyle Libre Pro System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use with Their Patients 200

6.26 Sep 27, 2016: PositiveID Announces Highlights for Third Quarter 2016 201

6.27 Sep 15, 2016: PositiveID to Present at the 2016 Aegis Growth Conference on September 22nd 202

6.28 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 202

6.29 Sep 07, 2016: Completed The First Subject in Clinical Study for Continuous Glucose Monitoring System in Hong Kong 203

6.30 Sep 07, 2016: Reimbursement of Dexcom CGM Technology for Patients with Type 1 and Type 2 Insulin-Dependent Diabetes is Now Available in Germany 204

6.31 Sep 06, 2016: Insulet Raises Private Placement of Senior Notes for USD300 Million 204

6.32 Sep 06, 2016: Insulet to Establish Highly-Automated Manufacturing Operation in the United States 205

6.33 Sep 06, 2016: Insulet Announces Executive Appointments 205

6.34 Sep 01, 2016: Medtronic Announces Approval Of Enlite Sensor For iPro2 Professional Continuous Glucose Monitoring System In The U.S. 205

6.35 Aug 25, 2016: M Pharma Raises USD1.5 Million in First Tranche of Private Placement of 10% Debentures Due 2019 206

6.36 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 206

6.37 Aug 25, 2016: Lee's Pharmaceutical Holdings: Interim Results For The Six Months Ended 30 June 2016 209

6.38 Aug 17, 2016: Guided Therapeutics Reports Second Quarter 2016 Financial Results; Year to Date Revenue Up 71% Over Same Period Last Year 211

6.39 Aug 15, 2016: PositiveID Reports Q2 2016 Revenue of $1.8 Million, Up from $51 Thousand in Q2 2015 212

6.40 Aug 12, 2016: Echo Therapeutics Announces Second Quarter 2016 Financial Results 213

6.41 Aug 11, 2016: Tenax Therapeutics Announces Second Quarter 2016 Financial Results and Provides Corporate Update 214

6.42 Aug 09, 2016: Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System 215

6.43 Aug 04, 2016: Nemaura Medical, Completes Second FDA Pre-submission Meeting And Appoints Navigant To Submit IDE For Nemauras SugarBEAT System 216

6.44 Aug 04, 2016: Henry Schein Reports Second Quarter Financial Results 216

6.45 Aug 03, 2016: Insulet Reports Second Quarter 2016 Financial Results 218

6.46 Aug 02, 2016: DexCom Reports Second Quarter 2016 Financial Results 219

6.47 Jul 28, 2016: Tandem Diabetes Care Reports Second Quarter 2016 Financial Results 219

6.48 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 221

6.49 Jul 20, 2016: Abbott Reports Second-Quarter 2016 Results 222

6.50 Jul 19, 2016: FDA Posts Briefing Documents Ahead of Advisory Committee Meeting 224

6.51 Jul 19, 2016: Medtronic Expands Continuous Glucose Monitoring Solutions for People with Diabetes Using Insulin Injections with CE Mark Receipt 225

6.52 Jul 12, 2016: PositiveID Announces Highlights for First Half of 2016 226

6.53 Jul 08, 2016: Ossen Innovation to Acquire 90.27% Stake in San MediTech from America-Asia Diabetes Research Foundation 226

7 Appendix 259

7.1 Methodology 259

7.2 About GlobalData 262

7.3 Contact Us 262

7.4 Disclaimer 262

1.2 List of Figures

Figure 1: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 20

Figure 2: Continuous Glucose Monitoring Systems-Pipeline Products by Territory 21

Figure 3: Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 22

Figure 4: Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 23

Figure 5: Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 24

1.1 List of Tables

Table 1: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 20

Table 2: Continuous Glucose Monitoring Systems-Pipeline Products by Territory 21

Table 3: Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 22

Table 4: Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 23

Table 5: Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 24

Table 6: Continuous Glucose Monitoring Systems Companies-Pipeline Products by Stage of Development 25

Table 7: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 29

Table 8: A. Menarini Diagnostics S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 9: GlucoMen Day-Product Status 33

Table 10: GlucoMen Day-Product Description 34

Table 11: Abbott Diabetes Care, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

Table 12: FreeStyle Libre Glucose Monitoring System-Consumer Version-Product Status 35

Table 13: FreeStyle Libre Glucose Monitoring System-Consumer Version-Product Description 36

Table 14: Advanced Biosensors-Ohio, Llc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 15: Continuous Glucose Monitor-Product Status 37

Table 16: Continuous Glucose Monitor-Product Description 37

Table 17: Advanced Medical Electronics Corporation Pipeline Products & Ongoing Clinical Trials Overview 38

Table 18: Continuous Glucose Monitor-Product Status 38

Table 19: Continuous Glucose Monitor-Product Description 39

Table 20: Alcon Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 21: Smart Contact Lens-Diabetes-Product Status 40

Table 22: Smart Contact Lens-Diabetes-Product Description 40

Table 23: Arkal Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

Table 24: GlucoPod CGM System-Product Status 41

Table 25: GlucoPod CGM System-Product Description 42

Table 26: Azurite Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 43

Table 27: Blood Glucose Sensor-Product Status 43

Table 28: Blood Glucose Sensor-Product Description 43

Table 29: Bar-Ilan University Pipeline Products & Ongoing Clinical Trials Overview 44

Table 30: Biometric Watch-Product Status 44

Table 31: Biometric Watch-Product Description 44

Table 32: Bellco Srl Pipeline Products & Ongoing Clinical Trials Overview 45

Table 33: Low Frequency Electromagnetic Glucose Sensor-Product Status 45

Table 34: Low Frequency Electromagnetic Glucose Sensor-Product Description 45

Table 35: Bio-Impedance General Ltd. Pipeline Products & Ongoing Clinical Trials Overview 46

Table 36: MD Watch-Product Status 46

Table 37: MD Watch-Product Description 46

Table 38: Biorasis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 47

Table 39: Glucowizzard-Product Status 47

Table 40: Glucowizzard-Product Description 47

Table 41: BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Table 42: Smart Tattoo Glucose Sensor-Product Status 48

Table 43: Smart Tattoo Glucose Sensor-Product Description 48

Table 44: Biovotion AG Pipeline Products & Ongoing Clinical Trials Overview 49

Table 45: Multisensor Glucose Monitoring System-Product Status 49

Table 46: Multisensor Glucose Monitoring System-Product Description 49

Table 47: VSM 3 Glucose Monitoring System-Product Status 50

Table 48: VSM 3 Glucose Monitoring System-Product Description 50

Table 49: Brigham and Women's Hospital Pipeline Products & Ongoing Clinical Trials Overview 51

Table 50: Fluorescence Measurement Device-Product Status 51

Table 51: Fluorescence Measurement Device-Product Description 51

Table 52: CALISTO MEDICAL, INC. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 52

Table 53: Glucoband-Product Status 52

Table 54: Glucoband-Product Description 52

Table 55: Cardiff University Pipeline Products & Ongoing Clinical Trials Overview 53

Table 56: Non-Invasive Blood Glucose Meter-Product Status 53

Table 57: Non-Invasive Blood Glucose Meter-Product Description 53

Table 58: CGM3 Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Table 59: CGM Sensor-Product Status 54

Table 60: CGM Sensor-Product Description 54

Table 61: ConvaTec Healthcare B Sarl Pipeline Products & Ongoing Clinical Trials Overview 55

Table 62: Closed Loop Continuous Glucose Monitoring System-Product Status 55

Table 63: Closed Loop Continuous Glucose Monitoring System-Product Description 55

Table 64: Cyber Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 56

Table 65: Cybersensors Continuous Glucose Sensor-Product Status 56

Table 66: Cybersensors Continuous Glucose Sensor-Product Description 57

Table 67: Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 58

Table 68: Integrated iSense CGM And JewelPUMP-Product Status 58

Table 69: Integrated iSense CGM And JewelPUMP-Product Description 59

Table 70: DexCom Inc Pipeline Products & Ongoing Clinical Trials Overview 60

Table 71: DexCom CGM With Accu-Chek Insulin Delivery System-Product Status 60

Table 72: DexCom CGM With Accu-Chek Insulin Delivery System-Product Description 61

Table 73: Dexcom G4 PLATINUM Continuous Glucose Monitor-Product Status 61

Table 74: Dexcom G4 PLATINUM Continuous Glucose Monitor-Product Description 62

Table 75: GlucoClear-Product Status 62

Table 76: GlucoClear-Product Description 63

Table 77: GlucoClear-Second Generation-Product Status 63

Table 78: GlucoClear-Second Generation-Product Description 63

Table 79: Next-Generation Continuous Glucose Monitoring (CGM) Device-Product Status 64

Table 80: Next-Generation Continuous Glucose Monitoring (CGM) Device-Product Description 64

Table 81: DexCom Inc-Ongoing Clinical Trials Overview 65

Table 82: GlucoClear-Second Generation-Pilot Observation of Continuous Glucose Monitoring in Critically Ill Patients Under Consideration of Accuracy, Feasibility and Acceptance by Ward Staff 67

Table 83: Dexcom G4 PLATINUM Continuous Glucose Monitor-A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults with Type 1 Diabetes 67

Table 84: Dexcom G4 PLATINUM Continuous Glucose Monitor-A Single-center, Prospective, 'Open-label', Investigator-initiated Pilot Study Evaluating the Role of Continuous Glucose Monitor (CGM) Use Either Alone or with Remote Monitoring Capabilities 68

Table 85: Dexcom G4 PLATINUM Continuous Glucose Monitor-An Open-label, Randomized, Two-way, Cross-over Multicenter Study to Assess the Efficacy of Closed-loop Strategy as Compared to Multiple Daily Injections in Regulating Glucose Levels During 24 Hours in Adults with Type 2 Diabetes under Intensive Insulin Th 68

Table 86: Dexcom G4 PLATINUM Continuous Glucose Monitor-Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects 69

Table 87: Dexcom G4 PLATINUM Continuous Glucose Monitor-Long-term Effects of Continuous Glucose Monitoring in Patients with Type 1 Diabetes Treated with Multiple Daily Insulin Injections-Extension of CGMMDI Trial 69

Table 88: Dexcom G4 PLATINUM Continuous Glucose Monitor-Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient with Diabetes and Chronic Kidney Disease-Validation Study 69

Table 89: Dexcom G4 PLATINUM Continuous Glucose Monitor-Real-time Continuous Glucose Monitoring (RT-CGM) in Patients with Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY) 70

Table 90: Dexcom G4 PLATINUM Continuous Glucose Monitor-Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation-Part 2 70

Table 91: Dexcom G4 PLATINUM Continuous Glucose Monitor-The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy 71

Table 92: Dexcom G4 PLATINUM Continuous Glucose Monitor-Use of Zone-Model Predictive Control (MPC) Controller on the Diabetes Assistant (DiAs) Platform with Fault Detection in Adolescents with Type 1 Diabetes in the Outpatient Setting (UCSB Study) 71

Table 93: DirectSens GmbH Pipeline Products & Ongoing Clinical Trials Overview 72

Table 94: Continuous Blood Glucose Monitoring System-Product Status 72

Table 95: Continuous Blood Glucose Monitoring System-Product Description 72

Table 96: Eccrine Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 97: Sweatronics Electronic Patch-Product Status 73

Table 98: Sweatronics Electronic Patch-Product Description 73

Table 99: Echo Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Table 100: Gen 2 Symphony CGM System-Product Status 74

Table 101: Gen 2 Symphony CGM System-Product Description 75

Table 102: NextGen System-Product Status 75

Table 103: NextGen System-Product Description 75

Table 104: Symphony tCGM System-Home-Product Status 76

Table 105: Symphony tCGM System-Home-Product Description 76

Table 106: Symphony tCGM System-Hospital Critical Care-Product Status 77

Table 107: Symphony tCGM System-Hospital Critical Care-Product Description 77

Table 108: Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 78

Table 109: Viscosimetric Sensor-Product Status 78

Table 110: Viscosimetric Sensor-Product Description 78

Table 111: eLutions Integrated Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

Table 112: Optically-Efficient Miniaturized Raman Optical System-Product Status 79

Table 113: Optically-Efficient Miniaturized Raman Optical System-Product Description 79

Table 114: EyeSense GmbH Pipeline Products & Ongoing Clinical Trials Overview 80

Table 115: Eye Sensor-Product Status 80

Table 116: Eye Sensor-Product Description 81

Table 117: Fiber Optic Sensor-Product Status 81

Table 118: Fiber Optic Sensor-Product Description 82

Table 119: EyeSense GmbH-Ongoing Clinical Trials Overview 83

Table 120: Fiber Optic Sensor-Clinical Study for Continuous Glucose Monitoring System in Hong Kong 83

Table 121: Flowsion A/S Pipeline Products & Ongoing Clinical Trials Overview 84

Table 122: Diramo System-Product Status 84

Table 123: Diramo System-Product Description 85

Table 124: Globe Medical Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Table 125: Continuous Glucose Monitoring Device-Product Status 86

Table 126: Continuous Glucose Monitoring Device-Product Description 86

Table 127: GlucoLight Corporation Pipeline Products & Ongoing Clinical Trials Overview 87

Table 128: SENTRIS-100-Product Status 87

Table 129: SENTRIS-100-Product Description 87

Table 130: Glucometrics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

Table 131: Portable Blood Glucose Meter-Product Status 88

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A. Menarini Diagnostics S.r.l., Abbott Diabetes Care, Inc., Advanced Biosensors-Ohio, Llc, Advanced Medical Electronics Corporation, Alcon Inc, Arkal Medical, Inc., Azurite Technologies, Inc., Bar-Ilan University, Bellco Srl, Bio-Impedance General Ltd., Biorasis, Inc., BioTex Inc, Biovotion AG, Brigham and Women's Hospital, CALISTO MEDICAL, INC., Cardiff University, CGM3 Ltd, ConvaTec Healthcare B Sarl, Cyber Medical Ltd., Debiotech SA, DexCom Inc, DirectSens GmbH, Eccrine Systems Inc, Echo Therapeutics Inc, Ecole Polytechnique Federale de Lausanne, eLutions Integrated Systems, Inc., EyeSense GmbH, Flowsion A/S, Globe Medical Tech Inc, GlucoLight Corporation, Glucometrics, Inc., Glucometrix AG, Glucosense Diagnostics Ltd, GlucoSet AS, Glucovation Inc, GluMetrics Inc, Glusense Ltd, GlySens Inc, GlySure Ltd, G-Sense Ltd., Guided Therapeutics Inc, Hypo-Safe A/S, iGlyko, Inc., Institute of Biomedical Engineering (ISIB-CNR), Insulet Corp, Integrity Applications Ltd, Invivomon Inc., Invivosense ASA, iSense Corporation, Luminous Medical Inc, Massachusetts Institute of Technology, MASTInc, Medella Health Inc., Medical Wireless Sensing Ltd, Medtronic plc, Mellitor Ltd., Microchips Biotech Inc, mobiLIFE, Nemaura Medical Inc, Northwestern University, NovioSense B.V., Optiscan Biomedical Corp, Pignolo SpA, PositiveID Corp, Prediktor AS, Profusa, Inc., Roche Diagnostics International Ltd, San Meditech (Huzhou) Co., Ltd., Senseonics, Incorporated, SensiVida Medical Technologies, Inc., Senzime AB, Singapore Biomicro Pte Ltd, Stanford University, Tenax Therapeutics Inc, Terumo Corp, The Charles Stark Draper Laboratory Inc, Ultradian Diagnostics LLC, University of Bari Aldo Moro, University of Bath, University of California Berkeley, University of California San Diego, University of South Florida, University of Strathclyde, University of Texas at Arlington, Vytrace, Inc., Zyvex Corporation

A. Menarini Diagnostics S.r.l., GlucoMen Day; Abbott Diabetes Care, Inc., FreeStyle Libre Glucose Monitoring System-Consumer Version; Advanced Biosensors-Ohio, Llc, Continuous Glucose Monitor; Advanced Medical Electronics Corporation, Continuous Glucose Monitor; Alcon Inc, Smart Contact Lens-Diabetes; Arkal Medical, Inc., GlucoPod CGM System; Azurite Technologies, Inc., Blood Glucose Sensor; Bar-Ilan University, Biometric Watch; Bellco Srl, Low Frequency Electromagnetic Glucose Sensor; Bio-Impedance General Ltd., MD Watch; Biorasis, Inc., Glucowizzard; BioTex Inc, Smart Tattoo Glucose Sensor; Biovotion AG, Multisensor Glucose Monitoring System; Biovotion AG, VSM 3 Glucose Monitoring System; Brigham and Women's Hospital, Fluorescence Measurement Device; CALISTO MEDICAL, INC. (Inactive), Glucoband; Cardiff University, Non-Invasive Blood Glucose Meter; CGM3 Ltd, CGM Sensor; ConvaTec Healthcare B Sarl, Closed Loop Continuous Glucose Monitoring System; Cyber Medical Ltd., Cybersensors Continuous Glucose Sensor; Debiotech SA, Integrated iSense CGM And JewelPUMP; DexCom Inc, DexCom CGM With Accu-Chek Insulin Delivery System; DexCom Inc, Dexcom G4 PLATINUM Continuous Glucose Monitor; DexCom Inc, GlucoClear; DexCom Inc, GlucoClear-Second Generation; DexCom Inc, Next-Generation Continuous Glucose Monitoring (CGM) Device; DirectSens GmbH, Continuous Blood Glucose Monitoring System; Eccrine Systems Inc, Sweatronics Electronic Patch; Echo Therapeutics Inc, Gen 2 Symphony CGM System; Echo Therapeutics Inc, NextGen System; Echo Therapeutics Inc, Symphony tCGM System-Home; Echo Therapeutics Inc, Symphony tCGM System-Hospital Critical Care; Ecole Polytechnique Federale de Lausanne, Viscosimetric Sensor; eLutions Integrated Systems, Inc., Optically-Efficient Miniaturized Raman Optical System; EyeSense GmbH, Eye Sensor; EyeSense GmbH, Fiber Optic Sensor; Flowsion A/S, Diramo System; Globe Medical Tech Inc, Continuous Glucose Monitoring Device; GlucoLight Corporation, SENTRIS-100; Glucometrics, Inc., Portable Blood Glucose Meter; Glucometrix AG, Non-Invasive Blood Glucose Monitoring Device; Glucosense Diagnostics Ltd, Non-Invasive Blood Glucose Monitor; GlucoSet AS, GlucoSet Sensor; Glucovation Inc, SugarSenz Continuous Glucose Monitor; GluMetrics Inc, GluCath Intravascular Continuous Glucose Monitor; Glusense Ltd, Implantable Continuous Glucose Sensor; GlySens Inc, GlySens ICGM System; GlySens Inc, Second Generation ICGM System; GlySure Ltd, GlySure Continuous Glucose Monitoring System; G-Sense Ltd., G-Sense device; Guided Therapeutics Inc, Altea MicroPor Laser; Hypo-Safe A/S, HypoSafe Device; iGlyko, Inc., iGlyko System; Institute of Biomedical Engineering (ISIB-CNR) (Inactive), Electrical Impedance Spectroscopy-Glucose Monitoring; Insulet Corp, Integrated CGM With Next Gen OmniPod System PDM; Integrity Applications Ltd, GlucoTrack-DF-C; Integrity Applications Ltd, GlucoTrack DF-F; Invivomon Inc., Smart IV-Glucose Monitoring System; Invivosense ASA, IvSCGM Biosensor; iSense Corporation (Inactive), iSense CGM; Luminous Medical Inc, Argus Glucose Monitoring System; Massachusetts Institute of Technology, Glucose Sensitive Tattoo; MASTInc, Life Watch; Medella Health Inc., Smart Contact Lens; Medical Wireless Sensing Ltd, GlucoWiSe; Medtronic plc, Enhanced Enlite Glucose Sensor; Medtronic plc, Guardian Connect Mobile CGM System; Medtronic plc, Guardian Connect With Enlite 3; Medtronic plc, Harmony 1 Sensor; Medtronic plc, Harmony 2 Sensor; Medtronic plc, ipro 4 Glucose Monitoring System; Medtronic plc, ipro 5 Glucose Monitoring System Sensor; Medtronic plc, iPro3 Glucose Monitoring System; Mellitor Ltd., Implantable Glucose Sensor; Microchips Biotech Inc, Illume; mobiLIFE, GlucoReader; Nemaura Medical Inc, Second Generation sugarBEAT; Nemaura Medical Inc, sugarBEAT; Northwestern University, Continuous Glucose Sensor; Northwestern University, Nanofabricated Glucose Sensor; NovioSense B.V., Tear Glucose Sensor; Optiscan Biomedical Corp, OptiScanner 5000; Optiscan Biomedical Corp, OptiScanner 6000; Pignolo SpA, Glycolaser Device; PositiveID Corp, Fully Synthetic Glucose Sensing System; PositiveID Corp, GlucoChip; Prediktor AS, BioMKR Device; Profusa, Inc., Non-enzymatic Glucose Sensor; Roche Diagnostics International Ltd, Accu-Check Insight CGM; San Meditech (Huzhou) Co., Ltd., Dynamic Glucose Monitoring System; Senseonics, Incorporated, Eversense Continuous Glucose Monitoring System; SensiVida Medical Technologies, Inc. (Inactive), Glucose Monitoring System; Senzime AB, CliniSenz; Senzime AB, OneSenz; Singapore Biomicro Pte Ltd, Implantable Blood Glucose Monitoring Device; Stanford University, Closed-Loop Glucose System; Tenax Therapeutics Inc, Glucose Biosensor; Terumo Corp, CMOS Image Glucose Sensor; The Charles Stark Draper Laboratory Inc, Implantable Nanosensor; Ultradian Diagnostics LLC, Biologue; University of Bari Aldo Moro, Non-Invasive Continous Glucose Monitoring Sensor; University of Bath, Continuosly Monitoring Glucose Sensor; University of California Berkeley, Dropsense Continuous Glucose Monitor; University of California San Diego, Glucose Monitoring Tattoo; University of South Florida, Long Term Silicon Carbide (SiC) RF Antenna; University of Strathclyde, Smart Tattoo; University of Texas at Arlington, Nanotechnology Based Glucose Monitoring Device; Vytrace, Inc., Continuous Glucose Monitoring Device; Zyvex Corporation, GeNI

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