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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Architectural pillars

US court sees fines levied on Precision Lens as unconstitutional

Feb. 20, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
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Philips Brightview

Philips hit with US recall for Brightview SPECT systems

Feb. 16, 2024
By Mark McCarty
The U.S. FDA reported Feb. 15 that Philips USA, a subsidiary of Amsterdam-based Royal Philips NV, recalled three models of the Brightview line of single photon emission CT (SPECT) systems due to an incident in which the system detector fell.
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Environmental Protection Agency - US EPA

US House committee sends signal to EPA on EtO regulation

Feb. 15, 2024
By Mark McCarty
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
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U.S. Securities and Exchange Commission

US SEC may bump VC registration exemption threshold to $12M

Feb. 15, 2024
By Mark McCarty
The U.S. Securities and Exchange Commission (SEC) said Feb. 14 that it may elevate the threshold for registration of venture capital (VC) funds from $10 million to $12 million, a move that would exempt at least a few med-tech VC funds from registration requirements.
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MHRA logo

UK’s MHRA feeds £10M into ‘game-changing tech’

Feb. 14, 2024
By Mark McCarty
Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.
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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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