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Applications to the FDA for new devices that cited predicate devices subject to ongoing recalls resulted a higher risk of recall of the new devices, two research teams reported in the Journal of the American Medical Association (JAMA).
BioIntelliSense and care.ai have teamed up to combine their existing technologies to provide continuous monitoring from medical-grade wearables to improve clinical workflows in healthcare facilities.
An FDA inspection of an iRhythm Technologies facility in Irvine, Calif., resulted in a Form 483 to the firm for not establishing corrective and preventative actions, not submitting a medical device report (MDR), and other issues regarding the company’s cardiac monitoring system.
Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.
The FDA offers advice for 510(k) marketing submissions for photobiomodulation (PBM) devices — also known as low-level light therapy (LLLT) devices — in a new draft guidance.
An administrative law judge in Washington D.C., has ruled that certain Apple watches, starting with 2020’s Series 6 and continuing through current versions, infringe on pulse oximeter patents held by Masimo. The U.S. International Trade Commission will now consider whether to implement a ban on imports of the watches.
The FDA has issued separate warning letters to Olympus Medical Systems and its subsidiary Aizu Olympus for failure to report malfunctions of endoscopes and inadequate validations.