Power loss risks prompt FDA Class 1 recall designation for heart pump accessories
Editor's Note Sudden, unexpected shutdown and restart prompted the US Food and Drug Administration (FDA) to designate a class 1 recall—the most severe category reserved for serious risk of injury or death—for Abbot’s HeartMate Mobile Power Unit, which powers system controllers for the HeartMate 3 Left Ventricular Assist System (LVAS)…
Augmented reality gains FDA nod, 10k-case milestone in orthopedics, strides in outpatient surgery
Editor's Note Augmented reality (AR) guidance keeps surging in perioperative practice: Pixee Medical just secured FDA 510(k) clearance for its Knee+ NexSight system for total knee arthroplasty, while Augmedics’ xvision platform has already guided 10,000 US spine surgical procedures and is rolling out a new CT-Fluoro registration upgrade. According to…
AI monitoring, remote surgery advance
Editor's Note Recent reporting from Fierce Healthcare highlights two notable technology advances that promise to impact surgical patients and caregivers: an AI-driven blood pressure monitoring system and a remote-controlled endovascular robotics platform. The first development, from BD, is designed to help clinicians anticipate and manage dangerous blood pressure drops during…
FDA issues early alerts for intravascular catheters
Editor's Note The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18. In one reported incident, the sheath of a Novasight Hybrid catheter—a device used…
Literature review: Endoscope disinfection failures highlight need for stronger sterilization practices
Editor's Note High-level disinfection (HLD) fails to reliably eliminate harmful microbes from flexible endoscopes in real-world healthcare settings, according to a review of endoscope processing effectiveness published April 8 in the American Journal of Infection Control. The review highlights routine breaches in cleaning protocols and links contaminated endoscopes to numerous…
GAO urges HHS to improve drug shortage response coordination
Editor's Note The Government Accountability Office (GAO) has called on the Department of Health and Human Services (HHS) to implement a formal mechanism for coordinating efforts to address ongoing drug shortages, which continue to jeopardize patient care nationwide. In a report released April 9, 2025, the GAO highlighted the critical…
FDA clears AI platform for real-time surgical measurements
Editor's Note What is reportedly the first technology to allow dynamic, 3D, segmental visualization of anatomy during surgery earned a second 510(k) clearance from the US Food and Drug Administration, according to an April 8 press release from developer Proprio. Designed to let surgeons measure progress during surgery without scrubbing…
Study: MRI contrast agent causes harmful metal buildup in some patients
Editor's Note New research offers a potential explanation for why some patients retain toxic metals long after undergoing an MRI. Published in the journal Magnetic Resonance Imaging, the findings show that gadolinium contrast agents used in MRI scans may react with common dietary compounds to form harmful metal nanoparticles in…
FDA issues Class 1 recall for vascular cannulas
Editor's Note Aortic root cannulas from Medtronic are the subject of the latest US Food and Drug Administration (FDA) class 1 recall, the most serious category reserved for risk of injury or death. Affected products include the DLP Aortic Root Cannula, MiAR Cannula, and DLP Aortic Root Cannula with Vent…
FDA announces Class 1 recall for implantable ports
Editor's Note The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death. The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the…
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- AI monitoring, remote surgery advance