<body><div><figure><img src="https://img.particlenews.com/image.php?type=thumbnail_580x000&amp;url=3C9Olw_0wJNQfGS00" alt="https://img.particlenews.com/image.php?url=3C9Olw_0wJNQfGS00" width="1600" height="900" ><figcaption>Members of the FDA's device center speak at Advamed's The Medtech Conference. From left to right: Janet Trunzo of Advamed, CDRH Director Michelle Tarver, Jeff Shuren, Daniel Caños, Owen Faris and Troy Tazbaz. Elise Reuter/MedTech Dive</figcaption></figure><p>At Advamed’s The Medtech Conference last week, the new director of the Food and Drug Administration’s device center, Michelle Tarver, shared the agency’s priorities and upcoming directives. </p><p>The event in Toronto, which drew more than 4,000 people, featured discussions about upcoming policies with FDA leaders and their peers from Canada, Japan and other countries. Leaders from medical device companies including Johnson &amp; Johnson, Abbott Laboratories, GE Healthcare and Stryker also spoke at the conference. </p><p>During the week, several discussions focused on how artificial intelligence is regulated as a device, and questions about generative AI. Other sessions focused on the future of new laboratory developed test regulations in the U.S., medical device cybersecurity and diversity in clinical trials. </p></div></body>

Mountain View, CA

NewsBreak

Medtech Conference recap: New CDRH leader details approach; AI and LDTs in focus

At Advamed’s The Medtech Conference last week, the new director of the Food and Drug Administration’s device center, Michelle Tarver, shared the agency’s priorities and upcoming directives. The event in Toronto, which drew more than 4,000 people, featured discussions about upcoming policies with FDA leaders and their...