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Philips Respironics has once again recalled some of its DreamStation continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, this time for a potential programming flaw. Read More
Part 2 of our two-part series on the impact of artificial intelligence (AI) on medical devices focuses on the significant regulatory challenges.Read More
The Department of Justice (DOJ) has charged three former executives of Magellan Diagnostics for allegedly concealing a device malfunction that could produce inaccurately low lead test results, to improve Magellan’s bottom line while positioning the company to be acquired. Read More
Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the document, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar. Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the product. Read More