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Unimicro Medical Systems has been sent an FDA warning letter for failing to comply with the agency’s Quality System Regulation (QSR) in manufacturing needles used in laparoscopic surgery. Read More
After a long delay, the FDA said it has finally reached an agreement with medical device representatives on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Act (MDUFA). Read More
Two European devicemaker trade groups, one German and the other French, have joined the chorus calling on the European Union to postpone implementing its Medical Device Regulation (MDR), which took effect May 26, 2021, with a three-year transitional period that will end May 26, 2024. Read More
In a trial, the device demonstrated 89 percent accuracy compared with the standard of care, an invasive heart catheter to measure pulmonary capillary wedge pressure. Read More
LumiThera has announced positive 13-month findings from its LIGHTSITE III clinical study in which patients with dry age-related macular degeneration (AMD) were treated with the company’s Valeda light delivery system. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
The new company will have behind it almost 100 years of experience in insulin delivery, and approximately 2,000 employees in various countries. Read More