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Home » Authors » Mark McCarty

Articles by Mark McCarty

Michelle Tarver, FDA device center director

FDA confirms Tarver taking over at agency’s device center

Oct. 22, 2024
By Mark McCarty
The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
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United Kingdom flag, map

NICE sees need for more evidence for tests for ADHD

Oct. 22, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence endorsed the Qb Test by Qbtech AB of Stockholm to aid in diagnosis of attention deficit/hyperactivity disorder in those aged 6 to 17.
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U.S. Supreme Court

Loper Bright decision impacting US False Claims Act cases

Oct. 21, 2024
By Mark McCarty
The U.S. Supreme Court's landmark decision in the case of Loper Bright continues to reverberate across the legal landscape, including in the realm of False Claims Act litigation.
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medtronic minimed 780G

FDA recommends CT over MRI if device compatibility unknown

Oct. 21, 2024
By Mark McCarty
The U.S. FDA urged doctors and patients to use CT imaging if possible, when the MRI compatibility of any electronic implanted devices is unknown because problems with CT imaging are "extremely low" in these circumstances.
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Michelle Tarver, FDA device center director
Med Tech Conference 2024

Shuren confirms Tarver in as FDA’s device center director

Oct. 18, 2024
By Mark McCarty
The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
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U.S. Capitol building, Washington D.C.

Advamed hopeful House breakthrough device bill will pass in ‘24

Oct. 17, 2024
By Mark McCarty
The med-tech industry has been keen to see government fill in the so-called valley of death for breakthrough medical devices for some years, and 2024 may be the year it is finally done. Scott Whitaker, president and CEO of the Advanced Medical Technology Association said in an Oct. 16 press briefing that a House bill may pass during the upcoming lame duck session, bringing to a close an effort that has been the better part of a decade in the making.
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AI biotech research concept with lightbulb and digital background
2024 Med Tech Conference

CBO scoring impedes expanded Medicare digital benefit categories

Oct. 16, 2024
By Mark McCarty
The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.
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EU flags
2024 Med Tech Conference

EU's MDR pain points exacerbated by lack of member state harmony

Oct. 16, 2024
By Mark McCarty
The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.
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Gavel and vials
2024 Med Tech Conference

US Judicial Conference eyes third-party litigation funding

Oct. 15, 2024
By Mark McCarty
Third-party litigation funding has been a source of controversy in the U.S. over the past decade, but the practice drew little national scrutiny up to now.
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Gears with regulatory words

FDA adds ‘under construction list’ to guidance agenda for FY 2025

Oct. 14, 2024
By Mark McCarty
The U.S. FDA’s device center disclosed its guidance ambitions for this new fiscal year – a list that includes the usual A and B lists for draft and final guidances. However, the agency now has an “under construction” list of guidance ambitions, the status of which is entirely reliant on the agency’s resources.
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