FDA designates Class 1 recall for angiographic catheter
Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…
Healthcare finance leaders shift focus to external threats amid regulatory, economic uncertainty
Editor's Note A new Deloitte report shows healthcare finance leaders are increasingly focused on external business pressures, especially federal policy changes, tariffs, and economic volatility, Chief Healthcare Executive reported June 24. In contrast to prior surveys, where workforce and internal operations were top concerns, 84% of leaders now cite external…
Johnson & Johnson launches AI fund to advance surgical innovation
Editor's Note Johnson & Johnson MedTech has launched the Polyphonic AI Fund for Surgery to accelerate the development of artificial intelligence solutions aimed at improving surgical care before, during, and after procedures. According to the company’s June 25 announcement, the initiative brings together key partners, including NVIDIA and Amazon Web…
Survey: Most nurses plan to stay despite financial, staffing, job satisfaction concerns
Editor's Note Financial strain, stress, and uncertainty are not enough to deter many US nurses from saying their education and careers have been worthwhile. That is one reading of the results of Nurse.org’s 2025 Nurse Survey, which collected responses from more than 6,000 US nurses between January and April. Overall,…
Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula
Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…
FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes
Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
The Joint Commission, CHAI collaborate on scalable health AI standards
Editor's Note The Joint Commission and the Coalition for Health AI (CHAI) are partnering to set national standards for responsible artificial intelligence (AI) use in healthcare, according to a June 11 announcement from the organizations. This effort will deliver AI implementation guidance, tools, and a certification program to over 80%…
FDA publishes Baxter update to Novum IQ infusion pump instructions addressing underinfusion risk
Editor's Note Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare…
AI-powered smart glasses catch drug errors
Editor's Note An AI-powered wearable camera has achieved 99.6% accuracy in detecting potentially deadly drug mix-ups, including in the OR, NBC News reported May 25. Developed by Kelly Michaelsen, MD, at UW Medicine, the smart glasses scan medication labels in real time, alerting anesthesia providers to syringe-vial mismatches before drugs…
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