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Ambra Health drew a Form 483 for failing to report a recall to the FDA and properly investigate customer complaints, among other lapses observed during an inspection of its New York City facility. Read More
Medtronic’s extravascular (EV) implantable cardioverter–defibrillator (ICD) had a 98.7 percent successful defibrillation rate after implantation in a recent study, researchers reported in the New England Journal of Medicine. Read More
Future product development will focus on additional respiratory infections and sexually transmitted diseases, among others, the company said. Read More
If authorized, the test will be integrated into the company’s telehealth program — Cue Care —which enables users who test positive to seek prescribed COVID-19 treatment from a physician online. Read More
“For the time being, Lumos does not intend to further invest in activities directed towards securing U.S. clearance for FebriDx,” the company said. Read More
The FDA has extended the comment period for its draft guidance on LASIK devices by 30 days in response to multiple requests by device groups. Read More
General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More