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Home » Authors » Mark McCarty

Articles by Mark McCarty

Cardinal Health Monoject Disposable Syringes

US FDA clamps down on faulty syringes from two facilities in China

July 24, 2024
By Mark McCarty
The U.S. FDA literally wasted no time in posting twin warning letters to two companies in China that manufacture syringes that were the subjects of multiple recalls in the U.S.
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FDA icons and doctor

Maker of patient monitors hit with repeat citations in US FDA warning

July 23, 2024
By Mark McCarty
The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.
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AI biotech research concept with lightbulb and digital background

US PTO revisits subject matter eligibility for AI

July 23, 2024
By Mark McCarty
The U.S. Patent and Trademark Office has provided updated guidance on the question of patent subject matter eligibility for inventions that rely on artificial intelligence, stating that a patent claim that does little more than recite an abstract idea is not subject-matter eligible.
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Judge's gavel with US flag

A royalty pain: Zimmer liable for payments despite patent expiry

July 22, 2024
By Mark McCarty
Royalties for licensed patents ordinarily need not be paid after the underlying patent has expired, but the case of Zimmer Biomet Holdings Inc. v. Insall would seem to throw out a cautionary flag regarding such agreements.
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U.S. flag on columned building

Davita to pay $34.5 million to settle allegations of violation of AKS

July 22, 2024
By Mark McCarty
Denver-based Davita Inc. agreed to pay more than $34 million to settle allegations that the company violated the Anti-Kickback Statute (AKS) by not collecting management fees from physicians to induce referrals to the company’s dialysis clinics.
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US FDA restructures device center

July 19, 2024
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health has rewired its organizational structure on several fronts, including a promotion of its communication function into a “super office,” which the agency said will help it be more agile and responsive to its strategic priorities.
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US Ways and Means Committee eyes tax reform for life science R&D

July 18, 2024
By Mark McCarty
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
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US Medicare’s CED process draws fire for lack of predictability

July 18, 2024
By Mark McCarty
The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
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US Ways and Means Committee eyes tax reform for life science R&D

July 17, 2024
By Mark McCarty
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
Read More

Guardant Health hit with $900K-plus kickback settlement

July 17, 2024
By Mark McCarty
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
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