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Home » Authors » Mark McCarty

Articles by Mark McCarty

AI biotech research concept with lightbulb and digital background

Tempus Labs wins reversal of patent rejection over machine learning

Nov. 12, 2024
By Mark McCarty
Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question.
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U.S. Capitol building

Pricing questions tank MCI’s bid for Veterans Affairs contract

Nov. 11, 2024
By Mark McCarty
The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.
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Illustration of cryoblation procedure in breast

Icecure wins advisory nod for Prosense system for breast cancer

Nov. 11, 2024
By Mark McCarty
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
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AI-generated digital horse illustration

FDA eyes generative AI in upcoming advisory committee hearing

Nov. 8, 2024
By Mark McCarty
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
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Clinical data illustration

FDA webinar offers little insight into labeling aspects of PPI

Nov. 7, 2024
By Mark McCarty
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.
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EU flags in front of the Berlaymont building

Regulatory consultant dismissive of EU device shortage claims

Nov. 6, 2024
By Mark McCarty
The EU’s still-new regulations for medical devices and in vitro diagnostics are often seen as drivers of current or impending shortages of these products, but Oliver Eikenberg of regulatory consultancy Pure Global is unimpressed by such claims. Eikenberg said much of the drag on the EU system is engendered by device makers that are failing to get their regulatory affairs in order – a problem neither Brussels nor the notified bodies can fix.
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Product recall concept image

GE Healthcare reports field correction for Evair compressors

Nov. 6, 2024
By Mark McCarty
The FDA announced a class I recall of Evair compressors by Chicago-based GE Healthcare due to elevated levels of formaldehyde when the devices are used with specific models of Carescape or Engstron ventilators.
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Medicare puzzle

US CMS lauded, blasted for physician fee final rule for 2025

Nov. 5, 2024
By Mark McCarty
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
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US-capital-washington-congress-government.png

Congress poised to revisit site-neutral payment

Nov. 5, 2024
By Mark McCarty
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
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Product recall concept image

Smiths Medical announces recall of tracheostomy tubes

Nov. 4, 2024
By Mark McCarty
The U.S. FDA reported a class I recall of tracheostomy tube kits by Minneapolis-based Smiths Medical Inc., because of the risk of separation of the tube’s pilot balloon and inflation line.
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