Early experience with the FDA’s Breakthrough Devices program

More info on the Breakthrough Devices program here, in @NatureBiotech, including the explosive growth in the program and the limited evidence supporting market authorization (3/3) https://t.co/WqxI0GTF10

$RDGL "The FDA accepted ~70% of all manufacturer applications for breakthrough device designation (between 13 December 2016 and 1 January 2020)." https://t.co/cxtj9obRqU

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

@davidalim I thought 2019 CMS rule dealt with add-on payments: https://t.co/r0KFdVCLZ1; we wrote about early experience with BDP here: https://t.co/WqxI0GTF10; and I shared some first-blush thoughts and concerns here: https://t.co/huX61WBgDt. I need to re

We recently had a paper in @NatureBiotech on the Breakthrough Devices program. Long story short, designation is increasingly used and approvals primarily relied upon short-term, surrogate effectiveness endpoints (unclear if older adults in trials) (4/4) ht

RT @NatureBiotech: Early experience with the FDA’s Breakthrough Devices program https://t.co/rMcJMOlMH8 https://t.co/QIL2GjqWuh

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @JMRothberg: James Johnston, please join our team. @ButterflyNetInc @HyperfineR @liminalsciences @HealthTesseract @HomodeusInc @quantum_…

An important article about the FDA breakthrough designation program for devices, and the lack of both transparency and evidence. https://t.co/FKgaY0DbUJ

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

Early experience with the FDA’s Breakthrough Devices program https://t.co/p7NR4zBiEf https://t.co/F68uUsfOgw

RT @NatureBiotech: Early experience with the FDA’s Breakthrough Devices program https://t.co/rMcJMOlMH8 https://t.co/QIL2GjqWuh

James Johnston, please join our team. @ButterflyNetInc @HyperfineR @liminalsciences @HealthTesseract @HomodeusInc @quantum_si @aitherapeutics @YaleMed

Early experience with the FDA’s Breakthrough Devices program https://t.co/rMcJMOlMH8 https://t.co/QIL2GjqWuh

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

RT @jsross119: Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly…

Great work by @YaleMed student James Johnston, an overview of FDA's Breakthrough Device Program, which is being increasingly used to bring new medical devices to market, often on basis of limited clinical evidence and with few postmarket study requirements