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Home » Authors » Mark McCarty

Articles by Mark McCarty

UK’s NICE keen to develop evidence for the use of AI in radiotherapy contouring

Sep. 27, 2023
By Mark McCarty
Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.
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Gavel with whistle

Zap Surgical prevails over Elekta in Federal Circuit patent scrum

Sep. 26, 2023
By Mark McCarty
Patent challenges for radiotherapy equipment might not make the splash that in vitro diagnostic patents have, but Elekta AB and Zap Surgical Inc., have been locked in a dispute over an Elekta patent for the past four years.
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FDA’s premarket cybersecurity guidance encodes legislative imperatives

Sep. 26, 2023
By Mark McCarty
The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).
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U.S. Supreme Court

Attorney forecasts more US DOJ dismissals of False Claims Act cases thanks to Supervalu

Sep. 25, 2023
By Mark McCarty
The U.S. Supreme Court has heard two cases this year regarding the False Claims Act (FCA), including the Shutte v. Supervalu case, which the court has remanded to the Court of Appeals for the Seventh Circuit. However, even though the case has not come to a close, Jay Stephens of Kirkland & Ellis LLP, believes that the Supreme Court’s handling of Supervalu creates an environment in which the process of discovery will become much more burdensome for all involved.
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Medtech Europe presses Brussels for ‘accountable structure’ for oversight of regulation

Sep. 25, 2023
By Mark McCarty
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
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Patients urge FDA to work with CMS on coding issues for health equity purposes

Sep. 22, 2023
By Mark McCarty
The U.S. FDA’s Sept. 6 hearing of the Patient Engagement Advisory Committee (PEAC) tackled the question of health equity, a discussion that touched on several issues such as accessibility. One of the committee’s recommendations was that the FDA assist the Centers for Medicare & Medicaid Services (CMS) with the latter’s task of developing codes for payment, not the kind of task to which the FDA is typically assigned.
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Illustration of TAVR device

Analysis of registry data hints minimally symptomatic patients are good candidates for TAVR

Sep. 21, 2023
By Mark McCarty

The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.


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Bipartisan momentum gathering for reforms of US Medicare program

Sep. 20, 2023
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
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Laptop displaying FDA logo

Med-tech harmonization plan is a study in regulatory incrementalism

Sep. 20, 2023
By Mark McCarty
The U.S. FDA is still sorting through the feedback for its proposal to modestly align the Quality System Regulation with ISO 13485, but the agency has posted a draft four-year plan for regulatory harmonization that is substantially broader in scope than just quality management system considerations. While this proposal addresses a significant need for device makers working in multiple markets, the objectives include an assessment of at least nine non-FDA harmonization proposals by the end of fiscal year 2025, a clear indicator that harmonization will continue to be every bit the slog it has proven to be in recent years.
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Magnifying glass, FDA concept image

FDA converts conformity assessment pilot into a full-fledged program

Sep. 20, 2023
By Mark McCarty
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the agency has now converted the ASCA pilot into a full-blown regulatory program. Fortunately for both the FDA and industry, most of the guidance groundwork is already in place, making the ASCA program a ready-to-go method for streamlining at least one element of premarket applications for medical devices.
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