The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
Despite a couple of med-tech deals transacted this year and more liquidity in the market, early-stage medical device companies in Europe continue to struggle to raise funds. To attract interest from Venture Capital (VC) funds, these companies must ensure they have a disruptive technology, be willing to change their story, and do the math to ensure that VC firms who back them can get an adequate return, investors advised at the recent LSX World Congress in London.
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved.
Hologic Inc. moved to expand its breast surgery line with the acquisition of Endomagnetics Ltd. (Endomag) for a proposed $310 million. Endomag offers a magnetic system that allows precise localization of tumors in the breast and lymph nodes without the use of radioactive materials or wires, enabling greater preservation of healthy tissue. The transaction is expected to close in the second half of 2024.
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