Mark McCarty

Manassas

Regulatory Editor at BioWorld

Regulatory Editor at Clarivate

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Articles

CMS agrees to cover at-home ventilation for chronic respiratory failure

1 week ago | bioworld.com | Mark McCarty

CMS agrees to cover at-home ventilation for chronic respiratory failureThe U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease. BioWorld MedTech Regulatory Respiratory U.S. CMS Medicare
FDA releases another batch of regs for de novo decisions

1 week ago | bioworld.com | Mark McCarty

FDA releases another batch of regs for de novo decisionsIt appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm. BioWorld MedTech Regulatory Diagnostics U.S. De novo FDA
Advamed presses CMS to require MA plans to honor NTAP program

1 week ago | bioworld.com | Mark McCarty

Advamed presses CMS to require MA plans to honor NTAP programMedicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program. BioWorld MedTech Regulatory Cardiovascular U.S. CMS
MHRA advises industry that new requirements are now in place

1 week ago | bioworld.com | Mark McCarty

MHRA advises industry that new requirements are now in placeThe U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency. BioWorld MedTech Regulatory Europe MHRA
23andme genetic privacy concerns garner Congressional scrutiny

2 weeks ago | bioworld.com | Mark McCarty

23andme genetic privacy concerns garner Congressional scrutinyThe bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation. BioWorld U.S. Policy
23andme genetic privacy concerns garner Congressional scrutiny

2 weeks ago | bioworld.com | Mark McCarty

23andme genetic privacy concerns garner Congressional scrutinyThe bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation. BioWorld MedTech U.S. Policy
NHS deploying Histosonics' Edison to slash health care red tape

2 weeks ago | bioworld.com | Mark McCarty

NHS deploying Histosonics' Edison to slash health care red tapeThe U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs. BioWorld MedTech Financings Regulatory Europe MHRA
European Commission clamps down on Chinese med tech

2 weeks ago | bioworld.com | Mark McCarty

Home » European Commission clamps down on Chinese med techEuropean Commission clamps down on Chinese med techThe trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China. BioWorld MedTech Asia-Pacific Europe China Trade
Livanova petitions CMS to drop CED mandate for VNS for depression

2 weeks ago | bioworld.com | Mark McCarty

Home » Livanova petitions CMS to drop CED mandate for VNS for depression BioWorld briefs for June 10, 2025. BioWorld MedTech briefs for June 9, 2025. Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company... In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant... Omada Health Inc.
TGA files court action against Philips over CPAP foam controversy

2 weeks ago | bioworld.com | Mark McCarty

Home » TGA files court action against Philips over CPAP foam controversyTGA files court action against Philips over CPAP foam controversyAustralia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand. BioWorld MedTech Regulatory CPAP Asia-Pacific TGA