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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
Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More
Leading devicemakers have pushed back against the FDA’s proposed annual appraisals of companies that participate in the agency’s Voluntary Improvement Program (VIP). Read More