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:
- Exablate, manufactured by Insightec
- FoundationOne CDx, manufactured by Foundation Medicine
- Embrace, manufactured by Empatica
- Banyan BTI, manufactured by Banyan Biomarkers
- Trevo Retriever, manufactured by Concentric Medical
- IDx-DR, manufactured by IDx
- CustomFlex Artificial Iris, manufactured by Clinical Research Consultants
- MiniMed 670G system, manufactured by Medtronic MiniMed
- Zephyr endobronchial valve system, manufactured by Pulmonx
- RECELL Autologous Cell Harvesting Device, manufactured by Avita Medical
- Spiration valve system, manufactured by Spiration
- reSET-O, manufactured by Pear Therapeutics
- Optimizer smart system, manufactured by Impulse Dynamics
- Barostim Neo system, manufactured by CVRx
- OraQuick ebola rapid antigen test, manufactured by OraSure Technologies
- Tula system, manufactured by Tusker Medical
- EXALT Model D Single-Use Duodenoscope, manufactured by Boston Scientific
- Caption Guidance, manufactured by Bay Labs
- Ambu Duodeno system, manufactured by Ambu Innovation GmbH
- Cobas EBV, manufactured by Roche Molecular Systems
- Guardant360 CDx, manufactured by GuardantHealth
- FoundationOne Liquid CDx, manufactured by Foundation Medicine
- MiniMed 770G system, manufactured by Medtronic MiniMed
- Cobas BKV, manufactured by Roche Molecular Systems
- FoundationOne Liquid CDX, manufactured by Foundation Medicine
- NightWare kit, manufactured by NightWare
- INTERCEPT blood system for plasma, manufactured by Cerus
- Aprevo intervertebral body fusion device, manufactured by Carlsmed
- i-STAT Alinity system, manufactured by Abbott
- Shockwave intravascular lithotripsy system with the Shockwave C2 coronary intravascular lithotripsy catheter, manufactured by Shockwave Medical
- Portable neuromodulation stimulator, manufactured by Helius Medical
- Harmony transcatheter pulmonary valve system, manufactured by Medtronic
- Neurolutions IpsiHand upper extremity rehabilitation system, manufactured by Neurolutions
- Cognoa autism spectrum disorder diagnosis aid, manufactured by Cognoa
- Aprevo Transforaminal intervertebral body fusion device, manufactured by Carlsmed
- ADVIA Centaur enhanced liver fibrosis test, manufactured by Siemens Healthcare Diagnostics
- Canary tibial extension with Canary Health implanted reporting processor system, manufactured by Canary Medical
- Vivistim paired VNS system, manufactured by Microtransponder
- Paige Prostate, manufactured by Paige.AI
- EYE-SYNC, manufactured by SyncThink
- EaseVRx, manufactured by AppliedVR
- Koios DS, manufactured by Koios Medical
- CavaClear laser sheath, manufactured by Spectranetics
- Agili-C, manufactured by CartiHeal