Food and Drug Administration

The firings included 20 individuals in the FDA's Office of Neurological and Physical Medicine Devices.

The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.

David Rosen, a partner and public policy lawyer at Foley & Lardner, discusses the agency's recently wrapped Software Precertification Pilot Program and what it means for the future of digital health regulation.

Healthcare professionals other than physicians, dentists and veterinarians who have prescribing authority under state law can order prescription digital therapeutics. That could improve access, especially to devices that treat mental health conditions.

The news comes about a week after AppliedVR announced it raised $36 million in Series B funding.

Ellume began recalling the tests last month for giving false positive results.

The FDA said negative test results don’t appear to be affected.

The new clearance expands its insulin dosing support to bolus and premixed insulin titration for Type 2 diabetes.

Abbott has received clearance from the FDA for its imaging software that uses artificial intelligence to provide doctors a better view of blood flow and blockages in heart vessels.

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.