software as a medical device

Healthcare provider wearing a lab coat and a stethoscope looking at a tablet
Huma receives 510(k) Class II clearance for its disease-agnostic platform
By Jessica Hagen | 01:53 pm | June 13, 2023
The FDA clearance comes just three months after the company received EU MDR Class IIb certification for its configurable disease management platform.
Under COVID-19 pressure, healthcare finally embraces new digital tools
By Anthony Pannozzo | 05:20 pm | June 25, 2020
With the abrupt transition to telehealth, the paradigm of care has shifted from legacy thinking to digital innovation
As FDA's Pre-Cert plan takes shape, worries emerge about overreach
By Jonah Comstock | 05:43 pm | April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD).
Deloitte report offers guidance for FDA's upcoming software regulation pathway
By Dave Muoio | 04:40 pm | March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.