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Devicemaker CooperSurgical, a division of CooperCompanies, was slapped with a five-observation Form 483 for manufacturing problems primarily focused on its intrauterine device (IUD) Paragard T380A copper contraceptive. Read More
In a survey by the consulting firm Deloitte, device manufacturers said that the semiconductors they need are in such short supply that many will have to cut back on production. Read More
Non-White patients experience less accurate oxygen readings with pulse oximeters and receive less supplemental oxygen in intensive care units, researchers reported in the journal JAMA Internal Medicine. Read More
Boston, Mass.-based Healthy.io’s Minuteful Kidney test has gained 510(k) clearance from the FDA. The company called it a “landmark” first clearance for a device that detects kidney disease with urine analysis using a smartphone camera. Read More
“The ability to accurately differentiate between respiratory viruses with similar symptoms is essential if physicians are to ensure optimized care for each patient,” the company said. Read More
Xeljanz, a Janus Kinase Inhibitor, is FDA-approved for several indications, including for patients with moderate-to-severe active ulcerative colitis. Read More
South Korean devicemaker SD Biosensor (SDB) has inked a $1.53 billion purchase deal with Cincinnati, Ohio-based Meridian Bioscience, gaining an expanded foothold in the U.S. market. Read More