Uneasy feeling for US industry as detail emerges of 510(k) overhaul
This article was originally published in RAJ Devices
"These two preliminary reports recommend steps to strengthen and improve the 510(k) process and the use of science in decision making" and provide a "blueprint for smarter medical device oversight". That is the understated way in which Jeffrey Shuren, director of the US Food and Drug Administration's Center for Devices and Radiological Health, described what are likely to be the biggest changes to the regulation of low- to medium-risk medical devices for 34 years1.
You may also be interested in...
Artificial intelligence (AI) and machine learning took center stage at this year’s Radiological Society of North America meeting in Chicago, and the pervasiveness of AI tech in new product launches was further emphasized at the RSNA’s expanded AI Showcase exhibit.
The French start-up claims first-in-man success for heart valve “softening” treatment and plans further trials for an EU launch.
Market Intel: Precision Diagnostics And Focal Treatments Offer Personalized Approach To Prostate Cancer
The combined market for prostate cancer diagnostics and minimally invasive treatments is set to increase from $900m to $1.46bn in the next five years. But conservative treatment, or watchful waiting, is popular, limiting growth of newer, focal treatments.