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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

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FDA expands definition of in silico trials in computational modeling final

Jan. 18, 2024
By Mark McCarty
Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.
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US oncology doc groups team up to improve radiation payment rates

Jan. 17, 2024
By Mark McCarty
U.S. physicians who provide radiation services for cancer patients have a long-running feud with the Centers for Medicare & Medicaid Services over a series of payment rate cuts for their services, but these medical societies are now teaming up to address the issue. These medical societies are making the case that payment reform is not only critical for the future of radiation oncology but are also optimistic that congressional interest in the dilemma has quickened sufficiently to suggest that a congressional response may be on tap in 2024.
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Ivenix

Fresenius recalls Ivenix pumps due to mechanical problems

Jan. 16, 2024
By Mark McCarty
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
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Apple, Masimo continue to scrum over patents in US

Jan. 16, 2024
By Mark McCarty
The history of med-tech patent litigation is replete with long-running conflicts that test the willpower of the participants, which increasingly seems to be the case in a series of lawsuits between Masimo Corp. and Apple Inc.
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US FDA recognizes hydrogen peroxide as category A sterilant

Jan. 12, 2024
By Mark McCarty
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.
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Medicare rates limit use of IVUS in peripheral artery disease

Jan. 11, 2024
By Mark McCarty
Intravascular ultrasound is the preferred imaging modality for a number of procedures conducted on the circulatory system, including some procedures performed in the peripheral vasculature, but adoption is seen in some quarters as sub-optimal. A trio of medical journals have published a consensus statement pressing the case for more widespread utilization of IVUS for peripheral artery disease, but one of the sources of drag is poor Medicare reimbursement, a problem that might only be resolved in a piecemeal fashion.
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FTC delivers a privacy shot across the bow of MaaS providers

Jan. 11, 2024
By Mark McCarty
Privacy laws and enforcement in the U.S. are seemingly growing by the week on both the state and federal levels, with the Federal Trade Commission (FTC) serving as one of the players in the federal enforcement game. The FTC has released a statement warning developers of data that are working as model-as-a-service companies to be wary of any illicit uses of data acquired to assist in development of artificial intelligence algorithms, a warning that these developers and their customers would do well to heed.
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omnipod 5 recall

Insulet’s Omnipod leads 2024 device recalls

Jan. 10, 2024
By Mark McCarty
Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix.
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WLF sees First Amendment issues in US FDA draft off-label guidance

Jan. 10, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
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UK’s MHRA emphasizes harmonization in new regulatory roadmap

Jan. 9, 2024
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency finalized its plans for an overhaul of its med-tech regulatory system in a comprehensive approach that captures both in vitro diagnostics and artificial intelligence.
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