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Home » Authors » Mark McCarty

Articles by Mark McCarty

Canadian flag, gavel

Canadian firms take center stage in latest batch of FDA warnings

June 6, 2024
By Mark McCarty
Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.
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Coins, cash, calculator, pills

Illumina’s spinoff of Grail not necessarily the final chapter

June 5, 2024
By Mark McCarty
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
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Hand holding FDA blocks

Industry wary of US FDA’s draft guidance for device thermal effects

June 4, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is nonetheless expansive in a manner that raises serious questions.
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Man sleeping with CPAP machine

FDA receives petition to grant OTC status to CPAP machines

June 4, 2024
By Mark McCarty
The U.S. FDA has received a citizen petition to grant over-the-counter status to continuous positive airway pressure (CPAP) machines, an oddly timed petition given a recent enforcement action against one of the prime movers in the CPAP space.
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Cholesterol plaque in artery

Cleerly seeks US Medicare coverage of AI-enabled plaque analysis

June 3, 2024
By Mark McCarty
New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.
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Ribbons of digital data

Dissolution of UK Parliament leaves AI bill in limbo

June 3, 2024
By Mark McCarty
The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.
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U.S. flag on columned building

Innovasis, two execs hit with $12M fine over FCA allegations

May 31, 2024
By Mark McCarty
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.
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EU flags at European Commission building

European Council approves another extension of the IVDR

May 30, 2024
By Mark McCarty
The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.
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China and U.S. flags

​US FDA finalizes medical device destruction rule

May 30, 2024
By Mark McCarty
The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
Read More
Judge's gavel with US flag

ACLA files suit against US FDA over lab-developed test final rule

May 29, 2024
By Mark McCarty
The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.
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