FDA seeks comments on CADe devices for radiological imaging
This article was originally published in Clinica
Manufacturers making premarket notifications (510(k) submissions) to the FDA for computer-assisted detection (CADe) devices applied to radiology images and radiology device data are being invited to comment on draft guidance on the subject.
You may also be interested in...
The US healthcare reform proposals signed into law on 23 March include requirements on medical device companies to reveal payments or gifts they make to doctors. Peter Rixon takes a closer look at what the reforms’ “sunshine” provisions actually mean
Compliance, approvals, inspections and many other burning issues will be on the agenda of a US conference that takes place in the coming weeks.
Compliance, approvals, inspections and many other burning issues will be on the agenda of a US conference that takes place in early May.