Investigating FDA’s breakthrough device program

The FDA's breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies, a STAT investigation has found. ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

Sponsored by       FDA's breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies By Katie Palmer and Mario Aguilar Molly Ferguson for STAT In dozens of interviews with companies, regulatory experts, investors, and independent researchers, STAT found that many breakthrough recipients co-opt the label to promote their products and entice new investors. The program has grown dramatically as the breakthrough label has become a business imperative. “The number of breakthrough device designations have gone up so much, I think it’s pretty clear that definition has been applied very loosely,” said Rita Redberg, a cardiologist and health policy researcher at the University of California, San Francisco. Read More Sponsor content by AWS MARKETPLACE Enhance the clinician experience  By using technology solutions, clinicians can easily monitor, evaluate, and adapt care across patients, treatments, and workflows. Join this webinar to learn how clinicians identify how to pivot, respond, and provide a better patient experience. Register now. More great reads from STAT this week A psychedelic therapist allegedly took millions from a Holocaust survivor, highlighting worries about elders taking hallucinogens By Olivia Goldhill Covid hasn’t given up all its secrets. Here are 6 mysteries experts hope to unravel By STAT staff Multiple myeloma is usually detected late. Some researchers think a precursor could help catch it early By Angus Chen Kizzmekia Corbett on the pandemic, public service, and her path to becoming a scientist By Helen Branswell For kids with Down syndrome, a new device offers hope for treating difficult sleep problems By Theresa Gaffney Listen: Dismantling medical racism starts in the classroom By Nicholas St. Fleur With milestones on the horizon, Guardant Health CEOs lay out their vision for cancer detection By Jonathan Wosen Opinion: Medicine needs to do right by patients prescribed opioids By Haider J. Warraich Saturday, April 23, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser