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Home » Authors » Mark McCarty

Articles by Mark McCarty

U.S. FDA headquarters

FDA issues patent term extension data for multiple devices

Feb. 13, 2024
By Mark McCarty
The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.
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US PTO guidelines for AI suggest amplified need for documentation

Feb. 13, 2024
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.
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Clinical data illustration

US FDA hints at wider use of data monitoring for clinical trials

Feb. 12, 2024
By Mark McCarty
The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.
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Laptop displaying FDA logo

FDA to review list of essential items for public health emergencies

Feb. 12, 2024
By Mark McCarty
The U.S. FDA recently convened an advisory hearing to review the agency’s list of essential items for public health emergencies and led the hearing with its own list to which the advisory committee recommended numerous additions. How the FDA will respond remains to be seen, but the FDA’s list may grow significantly larger despite that industry representatives advised that existing supply chain redundancies would seem to suggest that some devices and associated items need not be subject to FDA supply chain oversight.
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Gears with regulatory words

IMDRF to revisit specialized regulatory pathways in meeting

Feb. 9, 2024
By Mark McCarty
The International Medical Device Regulators Forum will meet in Washington in March 2024, a location which would seem to guarantee robust attendance. The meeting agenda includes an extensive amount of time for specialized regulatory pathways, an effort to promote the incentives for development of orphan and pediatric devices across the globe.
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Health professional reviewing digital health data

US Senate evaluates site-specific use of AI in health care

Feb. 8, 2024
By Mark McCarty
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
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U.S. flag, stethoscope

Budget scoring a concern for breakthrough device coverage legislation

Feb. 7, 2024
By Mark McCarty
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
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US flag, Department of Health and Human Services flags

Opportunities for IVD, vaccine makers in US vector-borne disease plan

Feb. 7, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.
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Bio PulseOX FDA graphic

Data needed to fix intra-patient variability in pulse-ox accuracy

Feb. 6, 2024
By Mark McCarty
The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story.
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Gavel with whistle

DOJ pursues cardiac PET scan company for induced referrals

Feb. 6, 2024
By Mark McCarty
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.
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