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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to be used as real world evidence (RWE) in regulatory decision making for medical devices is the subject of an FDA draft guidance that will replace a previous guidance on the topic issued in 2017.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
CDRH has teamed up with three more collaborative device initiatives, including an international effort to leverage the power of AI to improve medical device quality and patient health. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
The law, slated to take effect Jan. 1, 2024, requires Colorado health insurers to cap the amount for an epi-pen at $60 for a two-pack of injectors. Read More
Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as use of these devices may cause serious injuries or death. Read More