Tag: Safety

FDA clears handheld robotic system for ultrasound-guided needle procedures

Editor's Note Mendaera has received US Food and Drug Administration (FDA) clearance for its Focalist system, a compact robotic device that aims to improve precision in ultrasound-guided needle-based procedures. Fierce Biotech reported the news July 9. As detailed in the article, Focalist device is intended to assist with a range…

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By: Matt Danford
July 21, 2025
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Preoperative, postoperative GLP-1s improve weight loss in bariatric surgery patients

Editor's Note Research shows using GLP-1 receptor agonists both before and after bariatric surgery is associated with greater total weight loss than surgery alone, according to a July 13 article in MedPage Today. The article focuses on a retrospective analysis of 568 patients presented at ENDO 2025, the annual meeting…

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By: Matt Danford
July 18, 2025
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FDA issues early alert for microbore extension sets

Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…

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By: Matt Danford
July 18, 2025
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FDA designates Class 1 recall for cranial drill

Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…

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By: Matt Danford
July 17, 2025
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Rehab hospitals face scrutiny over safety, profits

Editor's Note Although for-profit rehab hospitals have become highly profitable, a recent KFF Health News report highlights serious safety violations, including patient deaths due to carbon monoxide poisoning, medication errors, and falls.  Published July 15, the article delves into recent data and inspections of these facilities, particularly those run by…

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By: Matt Danford
July 17, 2025
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CMS 2026 proposed rule: Expanded ASC access, higher payments, tighter quality reporting

Centers for Medicare & Medicaid Services

Editor's Note The Centers for Medicare & Medicaid Services (CMS) just proposed sweeping changes to the Medicare Shared Savings Program and Physician Fee Schedule for calendar year 2026, including extensive changes to outpatient Medicare policy such as payment increases, expanded procedural access, and new quality reporting updates, as outlined in…

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By: Tarsilla Moura
July 16, 2025
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Five underreported health changes in 'big beautiful bill'

Editor's Note Although the newly enacted One Big Beautiful Bill Act is best known for major Medicaid cuts and a temporary Medicare Physician Fee Schedule increase, it also carries significant policy changes that could affect providers, patients, and the physician workforce, MedPage Today reported July 11. The article lists five…

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By: Matt Danford
July 16, 2025
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FDA designates Class 1 recalls for EVH system, infusion pump

Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…

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By: Matt Danford
July 16, 2025
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CMS proposes 2026 Medicare pay bump, targets wasteful spending

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has proposed a 3.62% increase to the 2026 Medicare physician fee schedule, according to a July 14 article in Fierce Healthcare. The proposed rule sets the conversion factor at $33.42, up from $32.35 in 2025. The increase reflects a 2.5%…

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By: Matt Danford
July 15, 2025
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Study: Stem cell strategy could eliminate kidney transplant patients’ need for immunosuppressants

Editor's Note A stem cell-based transplant method enabled most kidney recipients in a recent clinical trial to stop taking immunosuppressive drugs, according to a July 15 article in HealthDay. As detailed in the article, the approach was tested in a phase 3 multicenter, randomized controlled trial published in the American…

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By: Matt Danford
July 15, 2025
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