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AdvaMed notched a victory last Friday when the US Court of Appeals ruled in its favor in the latest saga over what the association describes as preventing “unauthorized and unregulated repair companies from hacking into life-saving medical devices.” Read More
A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More
Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according to inspections expert David Chesney. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. Read More
Nearly two years after the FDA approved hearing aids to be sold OTC without involvement of a licensed professional, a Government Accountability Office (GAO) study found that barriers to treatment remain, and stakeholders believe prices are too high. Read More
Recalled products from Medtronic and Megadyne have been deemed Class I by the FDA — Medtronic for a potential software issue and Megadyne for the potential for burn injuries during surgery. Read More