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Home » Authors » Mark McCarty

Articles by Mark McCarty

Hand holding ballot over box, US flag backdrop

Impact of 2024 election on med tech difficult to forecast

Nov. 15, 2024
By Mark McCarty
Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
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Eko Health Low EF Stethoscope

CPT code just the start of Eko’s coverage push for Sensora

Nov. 14, 2024
By Mark McCarty
Eko Health Inc. recently won a category III CPT code for its Sensora platform for cardiovascular disease detection. While a “cat III” CPT code hasn’t traditionally excited industry, the company is convinced that payers will respond because of the massive costs associated with cardiovascular disease.
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Cleerly Labs product suite

Cleerly scores win with four-MAC coverage of AI-QCT

Nov. 13, 2024
By Mark McCarty
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
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European Union flag with wooden gavel

New notified body survey highlights role of poor-quality submissions

Nov. 13, 2024
By Mark McCarty
The European Commission posted the results of the latest survey of notified bodies, and as the saying goes, there’s good news and bad news.
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Laptop displaying FDA logo

​Owens & Minor draws FDA warning for lack of sterilization documentation

Nov. 12, 2024
By Mark McCarty
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
Read More
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.
Read More
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.
Read More
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