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Here is Episode 10 about medical device innovation and priorities at the CDRH with Director Michelle Tarver.

Key highlights from this episode:

1. MedTech innovation is a strong focus. Dr. Tarver shares two specific examples of recent device approvals - a blood-based test for Alzheimer’s and Continuous Glucose Monitors.

2. Brief background of Dr. Michelle Tarver - did you know that she is a renowned Ophthalmologist from Johns Hopkins. On a more personal side, she comes from a military family going to her grandfather who served in WWII.

3. Focus on home healthcare, reducing hospital stays and rehospitalization.

4. Predictable pathway for device commercialization, integrating regulatory approvals with reimbursement clearances.

5. FDA’s TAP program for accelerating device innovation

6. How device reviewers are using Elsa, the AI assistant to accelerate learning and cut down review timeline

7. Breakthrough device designations as another mechanism to accelerate launch of innovative devices through close FDA-industry interactions.

Disclaimer

We do not have any affiliation with the FDA. We are sharing only publicly available information in this post.