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November 2025
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FDA draft guidance addresses pulse oximeter accuracy, AI devices

Editor's Note The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if…

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By: Matt Danford
January 7, 2025
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Report: Healthcare ransomware compromises millions of patient records, costs billions in downtime

Editor's Note Between 2018 and 2024, ransomware attacks on US healthcare organizations compromised nearly 89 million patient records and resulted in downtime costing an estimated total of $21.9 billion, according to a December 18 report from Comparitech. The report tallies 654 total ransomware incidents during this period targeting hospitals, clinics,…

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By: Matt Danford
January 3, 2025
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Hospitals continue to grapple with IV fluid shortage

Editor's Note US hospitals continue to face a shortage of intravenous (IV) fluids due to Hurricane-related damage to the Baxter manufacturing facility that was responsible for 60% of the nation’s supply, MedPage Today reported December 31. Citing a report from Baxter, the article notes that the manufacturer has restored eight…

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By: Matt Danford
January 2, 2025
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Proposed tariffs, stricter immigration policies threaten healthcare workforce, supply chain

Editor's Note Immigration and trade policies proposed by President-elect Donald Trump could exacerbate challenges with healthcare staff and medical supply chains, according to recent reporting from Modern Healthcare and The Hill. As detailed by Modern Healthcare, stricter immigration policies could impede efforts to recruit skilled international workers, exacerbating gaps in…

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By: Matt Danford
January 2, 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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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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Fitch Ratings: Hospital credit outlook improves amid stabilizing margins

Editor's Note The credit outlook for the nonprofit hospital sector improved from “deteriorating” to “neutral” in Fitch Ratings’ 2025 report, the first revision in more than 2 years. Healthcare Dive reported the news December 11.  According to the outlet, Fitch attributes the shift to “steady improvement” in hospital operating margins,…

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By: Matt Danford
December 17, 2024
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Annual Leapfrog Group awards recognize top hospitals, ASCs

Editor's Note The Leapfrog Group has announced its 2024 Top Hospital and Top Ambulatory Surgery Center (ASC) Award recipients December 17, honoring facilities for standout performance in patient safety and care quality. This year, the national employer watchdog organization named 134 hospitals and 31 ASCs as winners of the national…

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By: Matt Danford
December 17, 2024
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US obesity rates decline for first time in a decade

Editor's Note An analysis of trends in body mass index (BMI) and obesity among US adults from 2013 to 2023 reveals a slight but significant decline in obesity prevalence in 2023, marking the first decrease after years of steady increases. The findings are detailed in a December 13 JAMA Health…

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By: Matt Danford
December 16, 2024
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Surveyed nurses, physicians likely to quit

Editor's Note Nearly half of nurses and physicians surveyed for a KLAS Arch Collaborative report expressed a likelihood leaving their current organization within two years, with 21% of nurses and 13% of physicians actually departing. According to a December 6 report in HIT Consultant, this trend trend carries substantial financial…

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By: Matt Danford
December 13, 2024
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