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Home » Authors » Mark McCarty

Articles by Mark McCarty

United Kingdom flag, map

NICE to revisit its cost savings approach to health tech assessment

Feb. 11, 2025
By Mark McCarty
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
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Heart scientific overlay

MDMA calls for TTVR coverage to include expanded indications

Feb. 10, 2025
By Mark McCarty
The U.S. national coverage analysis for transcatheter tricuspid valve replacement drew support from cardiologists and device makers alike, but the Medical Device Manufacturers Association is urging CMS to plan ahead in its final coverage memo and consider the coverage needs outside the confines of the existing U.S. FDA-approved device.
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U.S. intellectual property illustration

Inari fends off Imperative’s quest for IPR over infringement lawsuit

Feb. 10, 2025
By Mark McCarty
The med tech patent wars conscripted another two companies via a patent infringement lawsuit between Inari Medical Inc. and Imperative Care Inc. — a struggle that is playing out in a California district court.
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U.S. flag and White House podium

Trump administration presents a mixed picture for med tech

Feb. 7, 2025
By Mark McCarty
The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.
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Product recall concept image

Device recalls, corrections back in play in month of February

Feb. 6, 2025
By Mark McCarty
The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.
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Medicare puzzle

MedPAC not ready to move on Medicare site-neutral payments

Feb. 5, 2025
By Mark McCarty
Site neutral payments under the U.S. Medicare program have been contentious for some time, and Congress seems poised to act on the issue in 2025. The Medicare Payment Advisory Commission is wary of making any recommendations as yet — a position that MedPAC may hold pending the collection of additional data.
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U.S. flag, stethoscope

Industry supportive of CMS move to tighten MA plans’ coverage

Feb. 5, 2025
By Mark McCarty
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
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MHRA logo

MHRA offers guidance on regulated, unregulated digital health apps

Feb. 4, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware that promotional claims could push a product from the unregulated to the regulated category.
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Hourglass on glowing circuit board, symbolizing time and technology

California AG advisory tightens down on AI in health care

Feb. 4, 2025
By Mark McCarty
U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.
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US flag, stock market chart, White House

Trump’s new tariffs likely to hit med tech, but impact uncertain

Feb. 3, 2025
By Mark McCarty
President Donald Trump’s penchant for tariffs as a negotiating tool was on full display when he slapped a 25% tariff on products coming from Mexico and Canada – which may already been suspended in the case of Mexico. The actual impact of the tariffs on med tech is nonetheless tough to gauge due in no small part to the prospect that manufacturers will simply pass on at least part of the tariff to its customers in the U.S.
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