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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
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