FDA Announces Class II Status For 6 New Device Types
The newly classified devices were initially authorized via the de novo pathway.
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The newly classified devices include innovative products from Medtronic, Canary Medical and AppliedVR, among others.
The device classification announcements include four class II devices, as well as one that was placed in class I.
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.