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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

U.S. flag, stethoscope

Budget scoring a concern for breakthrough device coverage legislation

Feb. 7, 2024
By Mark McCarty
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
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US flag, Department of Health and Human Services flags

Opportunities for IVD, vaccine makers in US vector-borne disease plan

Feb. 7, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.
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Bio PulseOX FDA graphic

Data needed to fix intra-patient variability in pulse-ox accuracy

Feb. 6, 2024
By Mark McCarty
The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story.
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Gavel with whistle

DOJ pursues cardiac PET scan company for induced referrals

Feb. 6, 2024
By Mark McCarty
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.
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EU flags

EU nudges Artificial Intelligence Act further along

Feb. 5, 2024
By Mark McCarty
The European Union (EU) is steadily making progress on the Artificial Intelligence Act (AI Act), landmark legislation that will affect AI not just for medical uses, but for all uses across the EU economy.
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Woman scanning test tubes in the lab

Skepticism greets US FDA’s ramp-up of IVD reclassification program

Feb. 2, 2024
By Mark McCarty
The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.
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Gavel and FTC logo

Amgen-Horizon deal blasted as an example of FTC’s delaying tactics

Feb. 1, 2024
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
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U.S. at night from space with circuit board overlay

FDA staff can access management meeting notes in QMSR final rule

Jan. 31, 2024
By Mark McCarty
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
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Toy bulldozer moving FDA letter blocks

FDA’s real-world evidence draft expands data requirements

Jan. 30, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
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Laptop displaying FDA logo

FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
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View All Articles by Mark McCarty

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