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Home » Authors » Mark McCarty

Articles by Mark McCarty

Gavel and FTC logo

Trade associations push back on US PTO’s terminal disclaimer proposal

Aug. 1, 2024
By Mark McCarty
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
Read More
US flag, gavel, book

Maker of hip resurfacing system defeats US lawsuit via preemption

Aug. 1, 2024
By Mark McCarty
U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.
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Gavel and FTC logo

Trade associations push back on US PTO’s terminal disclaimer proposal

July 31, 2024
By Mark McCarty
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
Read More
U.S. flag on columned building

US AHRQ eyes multi-cancer detection tests in request for information

July 31, 2024
By Mark McCarty
The U.S. Agency for Healthcare Research and Quality posted a request for information on the current state of multi-cancer screening tests for a review that poses several questions.
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Medicare puzzle

Industry supportive of new DRG code for combination of procedures

July 30, 2024
By Mark McCarty
The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.
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U.S. FDA headquarters

US FDA eyes overhaul of guidance for maxillofacial systems

July 30, 2024
By Mark McCarty
The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.
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Guardant wins nod from FDA for Shield test for colorectal cancer

July 29, 2024
By Mark McCarty
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a year or two to emerge.
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guardant bloodkit

Guardant wins nod from FDA for Shield test for colorectal cancer​

July 29, 2024
By Mark McCarty
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Read More
Thyroid anatomy illustration

Austria’s HTA authority not yet sold on thyroid nodule thermoablation

July 29, 2024
By Mark McCarty
Thermoablation of thyroid nodules meets the patient’s standard of minimal invasiveness and is supported by the literature as an effective treatment for these nodules, which may become cancerous.
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Art concept for gene therapy research

NIH: AI good at diagnosis, not quite ready for prime time

July 26, 2024
By Mark McCarty
Artificial intelligence might solve a world of cost issues for medical science, but the results of a recent study suggest that the day has not yet come when hospitals and doctor’s offices can just feed data into a computer and expect a reliable and intelligible diagnosis.
Read More
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