More than 1,100 devices have received the FDA’s breakthrough designation

MedTech Dive August 21, 2025
Elise Reuter

The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.

Dive Brief:

A total of 1,176 products have received the Food and Drug Administration’s breakthrough device designation since 2015, according to the agency’s latest update on Wednesday.
The FDA gives the designation to devices that may provide more effective treatment or diagnosis of life-threatening or debilitating conditions. In its 2025 fiscal year, which began in October, the agency had granted 136 breakthrough designations as of June 30.
The FDA shared the update as medical device companies lobby for faster Medicare coverage of breakthrough devices.

Dive Insight:

Currently, Medicare has a pathway to provide national coverage to up...

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