Hematology Analyzers - Medical Devices Pipeline Assessment, 2018

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Hematology Analyzers Overview 9

3 Products under Development 10

3.1 Hematology Analyzers-Pipeline Products by Stage of Development 10

3.2 Hematology Analyzers-Pipeline Products by Segment 11

3.3 Hematology Analyzers-Pipeline Products by Territory 12

3.4 Hematology Analyzers-Pipeline Products by Regulatory Path 13

3.5 Hematology Analyzers-Pipeline Products by Estimated Approval Date 14

3.6 Hematology Analyzers-Ongoing Clinical Trials 15

4 Hematology Analyzers-Pipeline Products under Development by Companies 16

4.1 Hematology Analyzers Companies-Pipeline Products by Stage of Development 16

4.2 Hematology Analyzers-Pipeline Products by Stage of Development 17

5 Hematology Analyzers Companies and Product Overview 18

5.1 Abbott Diagnostics Company Overview 18

5.2 Analyticon Biotechnologies AG Company Overview 19

5.3 Apollo Medical Devices LLC Company Overview 20

5.4 Bio-AMD Inc Company Overview 21

5.5 Cell.Copedia GmbH Company Overview 22

5.6 Cellmic LLC Company Overview 23

5.7 Chromedx Corp Company Overview 24

5.8 Diatron Medical Instruments Limited Company Overview 26

5.9 Drew Scientific Co Ltd Company Overview 28

5.10 EKF Diagnostics Holdings Plc Company Overview 29

5.11 Entegrion Inc Company Overview 30

5.12 Ionu Biosystems Company Overview 33

5.13 IRIS International Inc Company Overview 34

5.14 Nova Biomedical Corp Company Overview 35

5.15 Quotient Limited Company Overview 36

5.16 Redbud Labs Inc Company Overview 40

5.17 Rutgers University Company Overview 42

5.18 Siemens Healthcare GmbH Company Overview 43

5.19 SigTuple Technologies Pvt Ltd Company Overview 44

5.20 SpinChip Diagnostics AS Company Overview 45

5.21 Sysmex America Inc Company Overview 46

5.22 University of British Columbia Company Overview 47

5.23 ViroGates AS Company Overview 49

6 Hematology Analyzers- Recent Developments 50

6.1 Jun 20, 2018: ChroMedX Appoints Tom Glawdel as Chief Scientific Officer and HemoPalm Science Lead 50

6.2 Jun 18, 2018: Quotient Limited to Host Investor Day on July 16, 2018 51

6.3 Jun 12, 2018: Rutgers Researchers Develop Automated Robotic Device For Faster Blood Testing 51

6.4 Jun 12, 2018: Daxor Names Kathryn A. Kornafel As Vice President Of Marketing And Commercial Development 51

6.5 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 52

6.6 Jun 11, 2018: Roche introduces first self-testing device for Warfarin monitoring with built in Bluetooth technology 52

6.7 Jun 07, 2018: End-to-end blood testing device could save practitioners time 54

6.8 Jun 04, 2018: Daxor Initiates Study with Virginia Commonwealth University to Measure Improvement of Survival Rates Following Burn Surgery As A Result of Optimized Blood Volume Assessment 54

6.9 Jun 01, 2018: ISBT Satellite Symposium Co-hosted by Ortho Clinical Diagnostics and Quotient Discusses Responding to the Challenges of Resource Constraints in Transfusion Diagnostics 55

7 Appendix 176

7.1 Methodology 176

7.2 About GlobalData 179

7.3 Contact Us 179

7.4 Disclaimer 179

List Of Figure

1.2 List of Figures

Figure 1: Hematology Analyzers-Pipeline Products by Stage of Development 10

Figure 2: Hematology Analyzers-Pipeline Products by Segment 11

Figure 3: Hematology Analyzers-Pipeline Products by Territory 12

Figure 4: Hematology Analyzers-Pipeline Products by Regulatory Path 13

Figure 5: Hematology Analyzers-Pipeline Products by Estimated Approval Date 14

Figure 6: Hematology Analyzers-Ongoing Clinical Trials 15

List Of Table

1.1 List of Tables

Table 1: Hematology Analyzers-Pipeline Products by Stage of Development 10

Table 2: Hematology Analyzers-Pipeline Products by Segment 11

Table 3: Hematology Analyzers-Pipeline Products by Territory 12

Table 4: Hematology Analyzers-Pipeline Products by Regulatory Path 13

Table 5: Hematology Analyzers-Pipeline Products by Estimated Approval Date 14

Table 6: Hematology Analyzers-Ongoing Clinical Trials 15

Table 7: Hematology Analyzers Companies-Pipeline Products by Stage of Development 16

Table 8: Hematology Analyzers-Pipeline Products by Stage of Development 17

Table 9: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 18

Table 10: Next Generation Hematology Analyzer-Product Status 18

Table 11: Next Generation Hematology Analyzer-Product Description 18

Table 12: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 19

Table 13: Hemolyzer 5-Product Status 19

Table 14: Hemolyzer 5-Product Description 19

Table 15: Apollo Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview 20

Table 16: Portable Blood Analysis System-Product Status 20

Table 17: Portable Blood Analysis System-Product Description 20

Table 18: Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 19: COAG Test Strip-Product Status 21

Table 20: COAG Test Strip-Product Description 21

Table 21: Cell.Copedia GmbH Pipeline Products & Ongoing Clinical Trials Overview 22

Table 22: CELLina-Product Status 22

Table 23: CELLina-Product Description 22

Table 24: Cellmic LLC Pipeline Products & Ongoing Clinical Trials Overview 23

Table 25: LUCAS-Product Status 23

Table 26: LUCAS-Product Description 23

Table 27: Chromedx Corp Pipeline Products & Ongoing Clinical Trials Overview 24

Table 28: HemoPalm-Product Status 24

Table 29: HemoPalm-Product Description 24

Table 30: HemoPalm-Version 3-Product Status 25

Table 31: HemoPalm-Version 3-Product Description 25

Table 32: Diatron Medical Instruments Limited Pipeline Products & Ongoing Clinical Trials Overview 26

Table 33: Abacus 380-Product Status 26

Table 34: Abacus 380-Product Description 27

Table 35: Drew Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

Table 36: DS360 HbA1c Analyzer-Product Status 28

Table 37: DS360 HbA1c Analyzer-Product Description 28

Table 38: EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 39: DiaSpect-Product Status 29

Table 40: DiaSpect-Product Description 29

Table 41: Entegrion Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Table 42: Viscoelastic Coagulation Monitor-Product Status 30

Table 43: Viscoelastic Coagulation Monitor-Product Description 30

Table 44: Entegrion Inc-Ongoing Clinical Trials Overview 31

Table 45: Viscoelastic Coagulation Monitor-Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) in Healthy Volunteers 32

Table 46: Ionu Biosystems Pipeline Products & Ongoing Clinical Trials Overview 33

Table 47: Fluorescent Smart Phone Blood Analyzer-Product Status 33

Table 48: Fluorescent Smart Phone Blood Analyzer-Product Description 33

Table 49: IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 50: 3GEMS Hematology Analyzer-Product Status 34

Table 51: 3GEMS Hematology Analyzer-Product Description 34

Table 52: Nova Biomedical Corp Pipeline Products & Ongoing Clinical Trials Overview 35

Table 53: Allegro Analyzer-Product Status 35

Table 54: Allegro Analyzer-Product Description 35

Table 55: Quotient Limited Pipeline Products & Ongoing Clinical Trials Overview 36

Table 56: MosaiQ-Product Status 36

Table 57: MosaiQ-Product Description 37

Table 58: Quotient Limited-Ongoing Clinical Trials Overview 38

Table 59: MosaiQ-Clinical Internal Evaluation of MosaiQ for Diagnosis of Blood Transfusion Diseases 39

Table 60: Redbud Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 61: ASAP Device-Product Status 40

Table 62: ASAP Device-Product Description 40

Table 63: HLS-Rugged Point-Of-Care Device-Product Status 41

Table 64: HLS-Rugged Point-Of-Care Device-Product Description 41

Table 65: Rutgers University Pipeline Products & Ongoing Clinical Trials Overview 42

Table 66: Integrated Blood Testing Device-Product Status 42

Table 67: Integrated Blood Testing Device-Product Description 42

Table 68: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 43

Table 69: ADCIA 2120 Hematology System-Product Status 43

Table 70: ADCIA 2120 Hematology System-Product Description 43

Table 71: SigTuple Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 72: Shonit-Product Status 44

Table 73: Shonit-Product Description 44

Table 74: SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 45

Table 75: SpinChip-Product Status 45

Table 76: SpinChip-Product Description 45

Table 77: Sysmex America Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 78: XW-100 Automated Hematology Analyzer-CLIA-Product Status 46

Table 79: XW-100 Automated Hematology Analyzer-CLIA-Product Description 46

Table 80: University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 47

Table 81: Portable Hematology Analyzer-Product Status 47

Table 82: Portable Hematology Analyzer-Product Description 48

Table 83: ViroGates AS Pipeline Products & Ongoing Clinical Trials Overview 49

Table 84: HemoSpec-Product Status 49

Table 85: HemoSpec-Product Description 49

Table 86: Glossary 178

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