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.
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.