44 ‘breakthrough’ medical devices that earned FDA approval

Becker's Healthcare April 19, 2022
Katie Adams

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
...

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