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Home » Authors » Mark McCarty

Articles by Mark McCarty

US Federal Circuit denies Dexcom’s petition to block Abbott’s IPRs

Jan. 8, 2024
By Mark McCarty
The U.S. Patent and Trademark Office’s inter partes review mechanism has drawn uneven reviews in the past decade or so and Dexcom Inc. has serious misgivings about an attempt by Abbott Diabetes Care Inc. to use the process to invalidate Dexcom patents for continuous glucose monitors.
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Swissmedic overhauls postmarket surveillance functions

Jan. 8, 2024
By Mark McCarty
Switzerland’s regulatory authority for devices and drugs, Swissmedic, decided to revamp how it organizes its postmarket surveillance work, and is also seeking to stand up its medical product surveillance database.
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’23 in review

FDA scrambled in 2023 to keep up with industry on AI

Jan. 5, 2024
By Mark McCarty
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023.
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’23 in review

FDA’s guidance for CDS sets new bar for controversy

Jan. 4, 2024
By Mark McCarty

The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.


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NICE sees mixed signals in evidence for lithotripsy in PAD

Jan. 3, 2024
By Mark McCarty

Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.


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Industry sees FDA’s 510(k) implant draft as excessive

Jan. 2, 2024
By Mark McCarty
At first glance, the U.S. FDA’s draft guidance for evidentiary expectations for 510(k) implants seems to demand more rigor on these applications, but some in industry believe that several of these elevated requirements offer little or no commensurate benefit. Geeta Pamidimukkala of the Advanced Medical Technology Association (Advamed) said the draft would seem to require that manufacturers preemptively explain the exclusion of animal testing, a requirement she said creates more work for both industry and FDA without offering a meaningful benefit.
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U.S. Capitol building

US FDA rolls out companion diagnostic pilot to overcome LDT problem

Jan. 2, 2024
By Mark McCarty
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
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Respironics hit with $2.5M settlement for FCA allegations

Jan. 2, 2024
By Mark McCarty
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
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Medicare puzzle
’23 in review

Medicare plan for US breakthrough device coverage is MIA in 2023

Dec. 29, 2023
By Mark McCarty

The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.


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Architectural pillars

Natera bests Neogenomics in district court patent litigation

Dec. 28, 2023
By Mark McCarty
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
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