The FDA’s Center for Devices and Radiological Health is facing a change in leadership as Jeff Shuren departs. Shuren’s legacy includes building trust with the medical device industry but facing criticism for risky products slipping through regulations. The FDA has also established its first advisory committee for digital health, focusing on AI-enabled medical devices. Meanwhile, a study warns about the dangers of buying weight loss drugs online without prescriptions. Hims & Hers exceeds Wall Street expectations, and 23andMe’s CEO’s plan to take the company private is rejected. Additionally, a cyberattack notification related to Change Healthcare’s hack has been posted by HHS.
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FDA’s digital health adcom takes shape
