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Impressive STAT investigation by Katie Palmer & Mario Aguilar on FDA’s breakthrough device program, its promise and current misuse; thanks for highlighting my concerns about tying BDP to CMS coverage and the need to generate evidence of patient benefit statnews.com/2022/04/18/fda…

A little surreal to see this, but immensely grateful to Kirk Williamson Mark Miller & everyone at Arnold Ventures for their support of our work with the Doctors for America FDA Task Force & @Yale_CRIT in advancing policies that truly protect our patients. arnoldventures.org/stories/physic…

Congress is currently finalizing the medical device user fee amendment (MDUFA) act. Working w/ Vinay Rathi (Mass Eye and Ear), Sanket Dhruva (UCSF Cardiology) and Rita Redberg, we review the history of the legislation, raise some concerns and make ... (1/2) nejm.org/doi/full/10.10…

🚨 Now out in JAMA Internal Medicine is a study by Brigham and Women's Medicine Residents James Johnston w/Joseph Ross & Reshma Ramachandran which looked at how often U.S. FDA approved new drugs between 2018-2021 with missed pivotal trial primary efficacy endpoints & FDA's rationale for approval: jamanetwork.com/journals/jamai…

How can FDA & CMS align policies to ensure that medical device innovation is based on strong and representative evidence? In a new JAMA Cardiology Special Communication, we explore market authorization and coverage for Breakthrough cardiovascular🫀 devices. jamanetwork.com/journals/jamac…

Centers for Medicare & Medicaid Services (CMS) should consider strengthening premarket evidence requirements for breakthrough medical devices to improve patient care and inform treatment decisions. ja.ma/4fCTrOI

To facilitate adoption of new medical devices, CMS can award💰 extra payments 💰 on top of standard reimbursement. In JAMA Health Forum, we characterized the evidence considered by CMS when approving or denying applications for outpatient Medicare supplemental payments.

To my family, wife (Tanvee Varma, MD), and friends—thank you for your belief in me To my dad specifically (my cardiology idol)—I inch a little more forward today as I continue to chase your footsteps I am elated to join MGH Cardiology Fellows as a cardiology fellow very soon! 🫀🩺

(1/12) New in JAMA Internal Medicine: we assess the performance of U.S. FDA's Breakthrough Devices Program across its first 8 years, with a focus on: ⏲️ Review times 💡Innovation 📊 Evidence CC: Joseph Ross Reshma Ramachandran Harlan Krumholz James Johnston