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.

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.

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.

The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.

Abbott Laboratories received U.S. FDA approval for its Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system for use in chronic limb-threatening ischemia well ahead of the expected second half 2024 time frame. Esprit showed clear superiority to angioplasty in the LIFE-BTK trial presented at last year’s Transcatheter Cardiovascular Therapeutics conference and published in The New England Journal of Medicine.

The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.”