Editor's Note The US Food and Drug Administration (FDA) and US Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to identify and eliminate outdated healthcare regulations, according to a May 13 press release from the FDA. The move supports a broader federal deregulatory…

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Editor's Note The US Food and Drug Administration (FDA) is deploying generative AI across all its centers by June 30, aiming to accelerate drug reviews and reduce bureaucratic workload even as experts and critics express worries about data security, reliability, and other safety concerns. Medical Design & Outsourcing reported the…

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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)…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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