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

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