The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
The U.S. FDA has granted a breakthrough device designation to Ancora Heart Inc. for its Accucinch ventricular restoration system. The minimally invasive treatment is intended to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
The U.S. FDA’s two-day meeting of the patient engagement advisory committee (PEAC) covered a range of issues surrounding augmented reality (AR) and virtual reality (VR) products, but patient information and education was one of the key considerations. Naiem Nassiri of Yale Medicine cautioned, however, that a 15-minute briefing between doctor and patient during a face-to-face encounter would likely create more confusion than clarity, a conclusion that would suggest that other patient education methods will likely be needed.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception.
The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
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