Citing reporting from the Pittsburgh Post-Gazette and ProPublica, US senators Dick Durbin, D-IL, and Richard Blumenthal, D-CT, are calling for the Government Accountability Office (GAO) to review the FDA’s oversight of medical device recalls.
News We’re Watching: Senators Call For Recall Info, TriClip Gets Panel Date
This week, US Senators Dick Durbin and Richard Blumenthal asked a government watchdog to review the FDA’s device recall authority; the FDA announced a panel date for Abbott’s MitraClip; and the DermaSensor skin cancer detection tool got FDA authorization.
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As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
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EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
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This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.