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The FDA has drawn mixed reactions to its draft guidance on reducing healthcare disparities in its Breakthrough Devices program, including support for creating greater flexibility for entry into the program, but also concerns about approvals that might lack sufficient evidence and ultimately jeopardize patient safety. Read More
Back pain sufferers using DarioHealth’s UpRight posture biofeedback platform at least six hours a day for four weeks saw significantly reduced pain and improved posture, researchers from the company reported in the journal Frontiers in Physiology.Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance and templates to help devicemakers in filing the newly-required Periodic Safety Update Reports (PSURs) based on postmarket surveillance. Read More
AdvaMed has filed an amicus brief with the U.S. Supreme Court seeking reversal of a California appeals court’s $300 million ruling against medical device maker Ethicon, arguing that the court applied the state’s consumer protection laws too broadly. Read More
Reviewing the deficiencies cited in FDA’s Form 483s inspection reports to devicemakers, just five areas account for almost 25 percent of all the observations by agency investigators each year. Read More
An FDA inspection of Apneicare’s medical device facility in Columbus, Ohio, turned up several repeat observations, including problems with handling complaints, completing corrective action reports and updating product labeling. Read More