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BioWorld - Monday, December 15, 2025
Home » Authors » Mark McCarty

Articles by Mark McCarty

Environmental Protection Agency - US EPA

EPA to reconsider air standards for ethylene oxide

March 28, 2025
By Mark McCarty
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
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US flag and HHS logo

HHS to cut staffing levels by 20,000 under efficiency initiative

March 27, 2025
By Mark McCarty
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000.
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Bhattacharya-Makary

Senate votes in Makary, Bhattacharya at FDA and NIH

March 26, 2025
By Mark McCarty
The U.S. Senate has approved the nominations of two key members of the Trump administration, Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director. While these are two of the most critical appointments for the Trump administration, the Senate still has two other important appointments in queue, including the directors of the Centers for Medicare & Medicaid Services and the CDC.
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Dexcom G7 CGM

FDA says changes in Dexcom G6, G7 sensors constitute misbranding

March 26, 2025
By Mark McCarty
The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
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CMS logo and website

Oz hits Wyden’s wall of skepticism in Senate CMS post hearing

March 25, 2025
By Mark McCarty
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
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Product recall concept image

Smith’s Medical removes endotracheal tubes due to small diameter

March 25, 2025
By Mark McCarty
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
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Medicare puzzle

Congress revisits the Medicare radiation oncology rate controversy

March 24, 2025
By Mark McCarty
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
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European Commission headquarters

European Commission eyes oversight of third-party litigation funding

March 24, 2025
By Mark McCarty
Third-party litigation funding (TPLF) has a checkered reputation in the U.S. med-tech industry and the practice has now raised hackles in the European Union as well. The European Commission recently posted a document explaining how EU-wide legislation would map onto member state law, the results of which suggest that any pan-EU legislation would be at best a tricky exercise in policymaking.
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Health professional touching screen, digital/medical icons

AI legislation advances in US states as Washington dithers

March 21, 2025
By Mark McCarty
Several American states are forging into a legislative vacuum where regulation of AI is concerned as Congress continues to delay action. Adoption of AI regulations on a state level increases the risk of a fragmented regulatory landscape, as already exists in U.S. privacy law, further complicating the path forward for med-tech companies deploying AI algorithms.
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Evoque valve sizes

US Medicare’s TTVR aligns closely with draft, T-TEER devices en route

March 20, 2025
By Mark McCarty
The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.
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