Mark McCarty

Manassas

Regulatory Editor at BioWorld

Regulatory Editor at Clarivate

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Articles

Noridian eyes coverage of Invitae test panel for heritable aortic disease

1 day ago | bioworld.com | Mark McCarty

Home » Noridian eyes coverage of Invitae test panel for heritable aortic disease BioWorld briefs for May 13, 2025. BioWorld MedTech briefs for May 13, 2025. After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,... Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategyâ€™s ultimate clinical...
FDA warns ICU Medical for fixes for infusion pump

1 day ago | bioworld.com | Mark McCarty

FDA warns ICU Medical for fixes for infusion pumpThe U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems.
Case draws more refined line for Anti-Kickback violations

2 days ago | bioworld.com | Mark McCarty

Case draws more refined line for Anti-Kickback violationsDevice makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone. BioWorld MedTech Regulatory U.S. Courts
NICE sees room for digital health for chronic tics and Tourette

3 days ago | bioworld.com | Mark McCarty

Home » NICE sees room for digital health for chronic tics and TouretteNICE sees room for digital health for chronic tics and TouretteThe U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome. BioWorld MedTech Regulatory Neurology/psychiatric Digital health Europe NICE
FDA to conduct unannounced inspections at OUS sites

6 days ago | bioworld.com | Mark McCarty

FDA to conduct unannounced inspections at OUS sitesThe U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard. BioWorld MedTech Regulatory Artificial intelligence U.S. FDA Policy
FDA posts regulation for 2018 test for hematological malignancies

1 week ago | bioworld.com | Mark McCarty

FDA posts regulation for 2018 test for hematological malignanciesThe U.S. FDA in 2018 granted the de novo petition by Seattle-based Adaptive Biotechnologies Corp. for the company’s DNA test for evaluation of residual hematological malignancies, but waited until March 8, 2025, to post notice of the attendant regulation. BioWorld MedTech Regulatory U.S. FDA
Congress poised to revisit two legislative proposals for patents

1 week ago | bioworld.com | Mark McCarty

Congress poised to revisit two legislative proposals for patentsLegislators in Washington again are considering a pair of bills that would affect how patents are obtained and sustained including the Patent Eligibility Restoration Act of 2025. This would constitute a big win for companies in the life sciences thanks to provisions that clarify just what is and is not eligible for patent protection. BioWorld BioWorld MedTech Regulatory U.S. Legislation Patents
Q’apel’s withdrawal of Hippo ends patent lawsuit with Route 92

1 week ago | bioworld.com | Mark McCarty

Q’apel’s withdrawal of Hippo ends patent lawsuit with Route 92Q’apel Medical Inc., of Fremont, Calif., might have thought the company’s withdrawal of the Hippo catheter was nothing but a loss, but Route 92 Medical Inc. managed to shine a positive light on the withdrawal by dropping a patent lawsuit against Q’apel because of the Hippo device. BioWorld MedTech Regulatory U.S. Patents
UK’s NICE seeks to apply price pressures on drug-eluting stents

1 week ago | bioworld.com | Mark McCarty

Home » UK’s NICE seeks to apply price pressures on drug-eluting stents BioWorld briefs for May 6, 2025. BioWorld MedTech briefs for May 6, 2025. The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the... The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the...
CMS vows to put more emphasis on MA plans’ prior authorization

1 week ago | bioworld.com | Mark McCarty

MDMA annual meetingCMS vows to put more emphasis on MA plans’ prior authorizationPhysicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight. BioWorld MedTech Regulatory Medical Device Manufacturers Association U.S. CMS Medicare