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January 2025
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FDA designates Class 1 recalls for balloon catheters, radiographic markers

Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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By: Matt Danford
December 19, 2024
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Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance

Editor's Note Robotic-assisted surgical procedures are no longer futuristic—they are becoming a mainstay in modern ORs. While Intuitive Surgical’s da Vinci system has led the market since 2001, competitors Medtronic and Zimmer Biomet are building innovative portfolios to challenge its dominance, MarketBeat December 12 reports. Medtronic’s Hugo Robotic Assisted Surgery…

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By: Tarsilla Moura
December 18, 2024
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Anthem’s anesthesia time limit policy, reversal sparks new legislation

Editor's Note Anthem Blue Cross Blue Shield recently reversed its controversial plan to impose time limits on anesthesia coverage after intense backlash from the medical community, including anesthesiologists and patient advocates. The policy, aimed at curbing alleged overbilling, would have restricted payments based on average surgery times, a move critics…

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By: Tarsilla Moura
December 18, 2024
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Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion

Editor's Note Certain medical bills reclassifying minor procedures as “surgery” are driving up costs and causing confusion among patients, KFF Health News December 13 reports. Cases such as a $414 charge for a splinter removal with tweezers and a $469 charge for freezing a skin tag highlight how CPT codes…

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By: Tarsilla Moura
December 18, 2024
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Antitrust guideline withdrawal could dampen M&A, boost uncertainty for provider joint ventures

Editor's Note In a move that could hinder provider-led joint ventures and increase regulatory uncertainty, the Federal Trade Commission (FTC) and the Justice Department have withdrawn antitrust guidance issued in 2000. Modern Healthcare reported the news on December 16. Passed in a 3-2 vote, the decision eliminates previously relied-upon safe…

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By: Matt Danford
December 18, 2024
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Infusion pump problems prompt early FDA safety warning

Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…

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By: Matt Danford
December 12, 2024
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Video details healthcare cybersecurity challenges

Editor's Note "Why is healthcare cybersecurity so bad?" This is the central question explored in a December 4 video from STAT health tech reporter Brittany Trang, who also wrote an article on the subject earlier this year. Brought into sharp focus by data exposures related to the recent attack on…

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By: Matt Danford
December 10, 2024
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Analysis: Guidance from leading medical journals mixed on AI use

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Editor's Note Leading medical journals vary significantly in guidance addressing the use artificial intelligence (AI) in medical research, according to an analysis published December 3 in JAMA Network Open.   The study categorized journals’ attitudes toward AI-assisted peer review into three groups: prohibition, limited use with conditions, and lack of explicit…

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By: Matt Danford
December 10, 2024
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Advanced practice providers fill capacity gaps amid continued scope-of-practice debates

Editor's Note A recent report in Becker’s Hospital Review illuminated health systems’ efforts to address physician shortage by integrating advanced practice providers (APPs) into care models. Citing projections from the Bureau of Labor Statistics (BLS), Becker’s noted that nurse practitioners (NPs) “are the fastest-growing occupation in the country, with employment in…

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By: Matt Danford
December 6, 2024
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FDA designates Class 1 recall for insulin syringes

Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…

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By: Matt Danford
December 5, 2024
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