44 ‘breakthrough’ medical devices that earned FDA approval

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