The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
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.
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.
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.
Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future.
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