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A recently approved position paper from the European Association of Medical Devices Notified Bodies — referred to as Team-NB — addresses the question “What should ‘lifetime’ mean in guidelines when referring to the lifespan of medical devices?” Read More
In this edition of Quick Notes, we look at FDA breakthrough designation for a pulsed ablation system for treatment of atrial fibrillation, an implant to treat glaucoma and ocular hypertension, a label expansion for a game-based digital therapeutic device for adolescents with ADHD, and an antigen test to detect the presence of a cancer-causing bacteria. Read More
Olympus Corporation of the America’s recall of 17,691 bronchofiberscopes and bronchovideoscopes due to burn and fire hazards has been identified as a Class I recall. Read More
Apple is pausing U.S. sales of its new Series 9 and Ultra 2 Apple watches due to a dispute with Masimo, a monitoring technologies medtech company, that alleges certain Apple watches violate its heart rate and blood oxygen monitor patents. Read More
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published an AI workplan intended to create a collaborative and coordinated strategy that will maximize AI’s benefits while managing the risks. Read More
In this edition of Quick Notes, we look at 510(k) clearances for an at-home intravaginal insemination kit, a fingertip blood collection device, first surgical navigation system for total ankle arthroplasty, a rapid anthrax toxin test, an AI-based chest x-ray triage solution, and an acute kidney injury biomarker test for pediatric use. Read More
How the FDA evaluates real world data (RWD) to determine if they are of sufficient quality to be used as real world evidence (RWE) in regulatory decision making for medical devices is the subject of an FDA draft guidance that will replace a previous guidance on the topic issued in 2017. Read More
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have asked the Government Accountability Office (GAO) to conduct a review of the FDA’s oversight of medical device recalls, citing a massive increase in adverse event reports and recall events in the past decade. Read More