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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
Masimo’s Opioid Halo system — the first FDA-authorized monitoring solution for detecting opioid-induced respiratory depression — has been granted a De Novo authorization for sale over the counter and by prescription. Read More
FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More
The Centers for Medicare and Medicaid Services (CMS) published a similar final rule in January 2021 that provided four years of Medicare coverage for innovative medical devices but later rescinded it later based on safety concerns. Read More
Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer. Read More
In this two-part series, FDAnews examines the dramatic impact of artificial intelligence (AI) on medical devices and the significant challenges it presents for regulators. Part 1 is an overview of the use of AI in medical devices.Read More