SaMD

A snapshot of productivity tools to arm healthcare professionals
By Joost Bruggeman | 03:09 am | July 10, 2020
The global workforce need the right tools as they continue to engage one of the greatest threats of our time with the resurgence of the coronavirus in China and marked increase in positive cases found in the US, says Joost Bruggeman, co-founder and CEO of Siilo.
Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
By Dave Muoio | 01:09 pm | June 04, 2019
At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.
FDA soliciting new volunteers to test drive its experimental Pre-Cert Program
By Dave Muoio | 04:07 pm | May 22, 2019
Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.
Deloitte report offers guidance for FDA's upcoming software regulation pathway
By Dave Muoio | 04:40 pm | March 13, 2018
Scoop: Emails show FDA asked Apple to advise on Software as a Medical Device
By Heather Mack | 01:35 pm | November 28, 2016