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The FDA has issued a Form 483 to Enthermics Medical Systems, based on an inspection last September of the company’s facility in Menomonee Falls, Wis. Read More
San Francisco, Calif.-based ProSomnus Sleep Technologies said that several postmarket studies of its EVO Sleep and Snore Device have shown it be an effective alternative to continuous positive airway pressure (CPAP) therapy in treating obstructive sleep apnea (OSA). Read More
After months of delay, the FDA and the device industry have reached an agreement in principle on the agency’s commitments for the fifth iteration of the Medical Device User Fee Act (MDUFA) – for fiscal years 2023 to 2027 — but the two sides are still working out details of a commitment letter that was due to Congress by Jan. 15. Read More
In a rare move by the FDA, the agency ordered Philips Respironics to notify patients and other customers of the company’s June 14, 2021, recall of certain models of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive-airway pressure (BiPAP) machines. Read More