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Home » Authors » Mark McCarty

Articles by Mark McCarty

Laptop displaying FDA logo

FDA not interested in extending comment period for LDT draft rule

Oct. 31, 2023
By Mark McCarty
The U.S. FDA’s draft rulemaking for regulation of lab-developed tests (LDTs) came with a conspicuously short comment period of 60 days, but the agency is unresponsive to requests to add another 30 days to the comment period.
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US Centers for Medicare & Medicaid Services ups base ESRD rate from draft rule

Oct. 31, 2023
By Mark McCarty

The U.S. Centers for Medicare & Medicaid Services (CMS) has released the prospective payment rule for end-stage renal disease (ESRD) for calendar year 2024, and advocates had some luck prompting the agency to boost the base ESRD payment rate. However, Atlanta-based Pain Care Labs Inc. came up short in its transitional add-on payment application for the Buzzy Pro for relief of puncture wound site pain because, according to CMS, the device does not represent a substantial improvement over currently available remedies.


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Olympus recalls UHI-4 high flow insufflation devices

Oct. 31, 2023
By Mark McCarty
Olympus Medical Corp. instituted a class I recall of its UHI-4 high flow insufflation device due to reports that the device may over-inflate and potentially create embolisms. The recall affects more than 3,100 units distributed in the U.S. between May 2012 and August 2023, all of which should not be used until the company resolves the problem.
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U.S. flag and White House podium

Biden administration seeks info on AI algorithms

Oct. 30, 2023
By Mark McCarty

The Biden administration has issued an executive order (EO) for artificial intelligence (AI), which addresses not only national security considerations, but public health considerations as well.


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Telehealth credited with boosting effectiveness of care for opioid-use disorder

Oct. 30, 2023
By Mark McCarty
Advocates of expanded use of telehealth in the U.S. may believe they have an unfairly high evidentiary bar to meet to bring payers on board, but that evidentiary requirement just received support from the National Institutes of Health (NIH).
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Illustration of Alzheimer’s in the brain.

CMS relaxes requirements for use of PET in detecting beta amyloids

Oct. 27, 2023
By Mark McCarty
The advent of FDA-approved therapies for Alzheimer’s disease has had some downstream regulatory effects, including that the Centers for Medicare & Medicaid Services recently announced it will eliminate the coverage with evidence development (CED) requirement for PET imaging for beta amyloid imaging for Alzheimer's disease.
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MDCG guidance on software-hardware combos an exercise in clarification

Oct. 26, 2023
By Mark McCarty
Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions.
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Tape measure wrapped around scale

UK’s NICE offers provisional coverage for weight management digital health software

Oct. 26, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) is offering provisional coverage for digital health technologies for specialist weight-management services as part of its early value assessment (EVA) series.
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US Congress, courts provide push, pull on EPA ethylene oxide rulemaking

Oct. 25, 2023
By Mark McCarty
The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization.
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Exagen hit with $650K fine for payment of specimen processing fees

Oct. 25, 2023
By Mark McCarty
Exagen Diagnostics Inc., of Vista, Calif., has agreed to pay slightly more than $653,000 to resolve allegations that it had paid specimen processing fees to physicians to induce those physicians to use Exagen’s lab tests.
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