9 More Devices Get Class II Status From US FDA
The newly classified devices include innovative products from Medtronic, Canary Medical and AppliedVR, among others.
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The newly classified devices were initially authorized via the de novo pathway.
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.