
James Johnston
@jljohnstonmd
UPMC Cardiology fellow | former @BrighamMedRes | Yale School of Medicine 2022
ID: 1286449747788730368
23-07-2020 23:55:03
9 Tweet
76 Followers
123 Following

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…




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
