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BioTelemetry, owned by Philips, and its subsidiary LifeWatch Services have agreed to pay more than $14.7 million to resolve allegations that they violated the False Claims Act by knowingly submitting claims to federal government programs for a higher level of cardiac monitoring than physicians intended to order. Read More
Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases, direct-to-consumer promotional labeling and advertisements and, reformulating drug products that contain carbomers manufactured with benzene. Draft guidance was issued on potency assurance for cellular and gene therapy products and quality considerations for topical ophthalmic drugs. Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
Apple decided on its own to stop selling the contended watches in December, well before the ban would have gone into effect following a presidential review, Masimo said. Read More
Acclarent, a division of Johnson & Johnson, has received FDA clearance for use of its AERA eustachian tube balloon dilation system in the treatment of children age 8-17 with persistent obstructive eustachian tube dysfunction (OETD), the first such treatment available for children. Read More
A five-year-old agreement between the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) on medical device cybersecurity should be updated to reflect new practices, according to a recent report by the U.S. Government Accountability Office (GAO). Read More
Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile neutropenia after chemotherapy. Read More
This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with several drug approvals in the U.S. and EU. Read More
While Apple’s request earlier this week for an interim stay of federal orders to stop selling its watches is hardly an emergency, according to Masimo, a federal court has agreed to Apple’s request and issued a temporary stay on the ban. Read More
As if lawsuits and plummeting stock prices from its faulty CPAP machines didn’t provide enough bad headlines, Philips now wants customers to pull the plug on one of its magnetic resonance imaging machines due to the potential for an explosion. Read More