44 'breakthrough' medical devices that earned FDA approval

The FDA's Breakthrough Devices Program has helped at least 44 medical devices become authorized and enter the market since it launched in 2015, the agency said April 15.

The FDA has given a "breakthrough" designation to more than 650 medical devices, according to the agency's website. The label does not indicate safety approval, but designates a product as potentially lifesaving and fast-tracks its development, testing and approval process.

Here are the 44 breakthrough devices that have obtained marketing authorization from the FDA, ordered chronologically from their authorization date:

1. Exablate, manufactured by Insightec
   
   
2. FoundationOne CDx, manufactured by Foundation Medicine
   
   
3. Embrace, manufactured by Empatica
   
   
4. Banyan BTI, manufactured by Banyan Biomarkers
   
   
5. Trevo Retriever, manufactured by Concentric Medical
   
   
6. IDx-DR, manufactured by IDx
   
   
7. CustomFlex Artificial Iris, manufactured by Clinical Research Consultants
   
   
8. MiniMed 670G system, manufactured by Medtronic MiniMed
   
   
9. Zephyr endobronchial valve system, manufactured by Pulmonx
   
   
10. RECELL Autologous Cell Harvesting Device, manufactured by Avita Medical
    
    
11. Spiration Valve System, manufactured by Olympus
    
    
12. reSET-O, manufactured by Pear Therapeutics
    
    
13. Optimizer smart system, manufactured by Impulse Dynamics
    
    
14. Barostim Neo system, manufactured by CVRx
    
    
15. OraQuick ebola rapid antigen test, manufactured by OraSure Technologies
    
    
16. Tula system, manufactured by Tusker Medical
    
    
17. EXALT Model D Single-Use Duodenoscope, manufactured by Boston Scientific
    
    
18. Caption Guidance, manufactured by Bay Labs
    
    
19. Ambu Duodeno system, manufactured by Ambu Innovation GmbH
    
    
20. Cobas EBV, manufactured by Roche Molecular Systems
    
    
21. Guardant360 CDx, manufactured by GuardantHealth
    
    
22. FoundationOne Liquid CDx, manufactured by Foundation Medicine
    
    
23. MiniMed 770G system, manufactured by Medtronic MiniMed
    
    
24. Cobas BKV, manufactured by Roche Molecular Systems
    
    
25. FoundationOne Liquid CDX, manufactured by Foundation Medicine
    
    
26. NightWare kit, manufactured by NightWare
    
    
27. INTERCEPT blood system for plasma, manufactured by Cerus
    
    
28. Aprevo intervertebral body fusion device, manufactured by Carlsmed
    
    
29. i-STAT Alinity system, manufactured by Abbott
    
    
30. Shockwave intravascular lithotripsy system with the Shockwave C2 coronary intravascular lithotripsy catheter, manufactured by Shockwave Medical
    
    
31. Portable neuromodulation stimulator, manufactured by Helius Medical
    
    
32. Harmony transcatheter pulmonary valve system, manufactured by Medtronic
    
    
33. Neurolutions IpsiHand upper extremity rehabilitation system, manufactured by Neurolutions
    
    
34. Cognoa autism spectrum disorder diagnosis aid, manufactured by Cognoa
    
    
35. Aprevo Transforaminal intervertebral body fusion device, manufactured by Carlsmed
    
    
36. ADVIA Centaur enhanced liver fibrosis test, manufactured by Siemens Healthcare Diagnostics
    
    
37. Canary tibial extension with Canary Health implanted reporting processor system, manufactured by Canary Medical
    
    
38. Vivistim paired VNS system, manufactured by Microtransponder
    
    
39. Paige Prostate, manufactured by Paige.AI
    
    
40. EYE-SYNC, manufactured by SyncThink
    
    
41. EaseVRx, manufactured by AppliedVR
    
    
42. Koios DS, manufactured by Koios Medical
    
    
43. CavaClear laser sheath, manufactured by Spectranetics
    
    
44. Agili-C, manufactured by CartiHeal