Keyword: Bradley Merrill Thompson
The FDA is making progress with its Pre-Cert program, but one attorney says "there is conflict."
The FDA's approval of an app that uses AI to notify specialists of a potential stroke offers new possibilities for triage software that uses CDS.
AMIA and CHIME called for more clarity regarding machine learning software, while CDS Coalition said the FDA's guidance would lead to patient harm.
The digital health industry waited six years for the FDA to release CDS guidance. Now that it's here, some say the agency didn't push far enough.
New guidance released by the FDA looks to ease the process for medical device updates, but it may only have a marginal effect.
A coalition devoted to clinical decision support software has finalized guidelines designed to self-regulate machine learning software.
The FDA has outlined basic concept of its new software precertification program, but companies selected for the pilot will have an outsized influence.
A new pilot program lays the groundwork for the FDA to overhaul its approach to regulating digital health companies that "fosters, not impedes, innovation."
The FDA will launch a Digital Health Innovation Plan that will redefine its approach to digital devices, prompting excitement from industry experts.
A coalition of providers and developers has released guidelines aimed at helping clinical decision support software developers self-regulate.