STAT+: Breakthrough Device Tracker: An authoritative database of FDA’s fast-tracked medical devices

The FDA's Breakthrough Device program is growing rapidly, but remains secretive. So STAT built a comprehensive database searchable by indication, manufacturer, regulatory pathway, and more.

The world of medical devices is growing more sprawling every day. Some promising novel ideas can take longer to wind their way through regulatory review and get to patients — so since 2017, the Food and Drug Administration has deployed a program for what it calls “breakthrough devices” to speed the process.

The program has surged significantly in size, but its implementation remains largely shielded from the public eye. So STAT identified as many breakthrough-designated devices as possible — more than two-thirds of the total to date — and created a tool to help users understand the FDA’s approach. You can filter by conditions, clinical areas, manufacturer, market pathway, and authorization status.

Continue to STAT+ to read the full story…