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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
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
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final rule in January 2021 that provided four years of Medicare coverage for innovative medical devices but later rescinded it later based on safety concerns.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
A bipartisan group of U.S. lawmakers has reintroduced proposed legislation to “modernize the review process for diagnostic testing” and clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS). Read More
Modifications needed to continually improve software functions for artificial intelligence (AI)-enabled medical devices must be made “in a manner that ensures the continued safety and effectiveness of the device,” the FDA emphasized in a draft guidance on predetermined change control plans (PCCPs) released Thursday. Read More
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections and many new medical products won’t get approved, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Read More