FDA accelerates medical device safety alerts to reach public within days
Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…
FDA has begun requiring electronic De Novo submissions for new medical devices
Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…
Private equity is reshaping ASCs, raising cost and antitrust concerns
Editor's Note Private equity is driving a quiet but powerful transformation in the $30 billion ambulatory surgery center (ASC) market, heightening risks of higher costs and reduced competition, an October 2025 research brief from the Private Equity Stakeholder Project (PESP) reports. It warns that Wall-Street-backed consolidation and opaque ownership structures…
Cuts to NIOSH, OSHA threaten decades of worker-safety progress
Editor's Note The dismantling of the National Institute for Occupational Safety and Health (NIOSH) jeopardizes worker safety nationwide and risks reversing decades of progress, New England Journal of Medicine October 4 reports. In April, sweeping federal workforce reductions eliminated more than 80% of NIOSH staff, closing laboratories and freezing core…
ACS launches hospital search tool to spotlight surgical quality
Editor's Note The American College of Surgeons (ACS) has launched a new online tool that helps patients and families locate hospitals recognized for delivering high-quality surgical care, according to an August 26 ACS announcement. The “Find a Hospital” tool highlights facilities that have earned ACS accreditation or verification through an…
Report warns sterile processing staffing crisis threatens surgical safety
Editor's Note Sterile processing departments (SPDs) face chronic staffing shortages and underinvestment that put surgical patients at risk, according to a Surgical Directions September 18 report. It emphasizes that sterile processing technicians, who decontaminate, inspect, and sterilize every surgical instrument, remain under-recognized despite their central role in surgical safety. Per…
AAAHC report spotlights top accreditation deficiencies, strategies for safer ambulatory care
Editor's Note Ambulatory care leaders can now sharpen compliance strategies with the release of the 2025 Quality Roadmap from the Accreditation Association for Ambulatory Health Care (AAAHC), published September 22. The annual report distills more than a year of survey findings into practical guidance for addressing the most common accreditation…
CMS proposal to end inpatient only list draws strong industry response
Editor's Note The plan to eliminate the Medicare Inpatient-Only (IPO) List and expand the Ambulatory Surgery Center Covered Procedures List (ASC-CPL) from the Centers for Medicare & Medicaid Services (CMS) has generated widespread reaction, with more than 3,900 comments submitted during the official feedback period, Ambulatory Surgery Center News September…
AI could shrink drug discovery from years to months, expert says
Editor's Note Artificial intelligence (AI) is poised to overhaul drug development, with DeepMind CEO Demis Hassabis predicting that discovery timelines could shrink from more than a decade to just months. In a September 13 article from the Times of India, Hassabis described how AI models can identify drug candidates faster,…
AMA 2026 CPT code set expands with AI, remote monitoring, leg revascularization updates
Editor's Note The American Medical Association (AMA) has released the 2026 Current Procedural Terminology (CPT) code set, introducing 288 new codes that capture emerging technologies and modern care delivery models, the association announced on September 11. In total, the update includes 418 changes: 84 deletions, 46 revisions, and the newly…
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