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Home » Authors » Mark McCarty

Articles by Mark McCarty

Product recall concept image

Abbott, Baxter and Medtronic among firms hit with recalls

Sep. 6, 2024
By Mark McCarty
The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
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U.S. flag on columned building

Planmeca hit with PHOSITA blues in patent litigation with Osseo

Sep. 5, 2024
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit shot down Planmeca’s argument that expert testimony provided by Osseo was disqualified because the expert was not a PHOSITA at the time the patented articles were developed, leaving Planmeca with a negative verdict in excess of $2 million.
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Man sleeping with CPAP machine

Philips, Soclean entangled in dueling lawsuits over CPAP cleaners

Sep. 4, 2024
By Mark McCarty
Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the interaction between CPAP machines and CPAP cleaning systems.
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FDA approval seal on blue glittering background

FDA still playing catch-up on de novo device classifications

Sep. 4, 2024
By Mark McCarty
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
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EU flags at European Commission building

European Court of Justice vacates decision in Illumina-Grail saga

Sep. 3, 2024
By Mark McCarty
The European Court of Justice declared that the European Commission was out of bounds in attempting to thwart Illumina Inc.’s proposed reacquisition of Grail Inc., which Illumina said relieves it of a fine of roughly €430 million (US$474.92 million).
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Illustration of leg anatomy with target around knee

NICE guardedly optimistic about scaffolds for knee cartilage repair

Sep. 3, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence sees some evidence that single-step insertions of scaffolds for knees with damaged cartilage offer significant benefits, calling for the use of registries for tracking of outcomes data.
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U.S. Capitol building

Congress looks to fix patent infringement injunction problem

Aug. 30, 2024
By Mark McCarty
The U.S. Congress is examining legislative language to address what some believe is a deteriorating state of jurisprudence for injunction when infringement is found in patent litigation.
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Man sleeping with CPAP machine

FDA cleans house on makers of CPAP cleaning systems

Aug. 29, 2024
By Mark McCarty
The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time.
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US flag, gavel, book

Variations in state interpretations of strict liability likely to persist

Aug. 28, 2024
By Mark McCarty
While product liability litigation in the U.S. for medical devices is a matter of state law, a legal theory from 1965 seemed to hint at a uniform national standard on strict liability for medical devices.
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Diabetes glucose monitor

Abbott scores $54M win in glucose test strip diversion case

Aug. 27, 2024
By Mark McCarty
A magistrate judge for a U.S. district court has recommend that Abbott Laboratories receive $54 million in damages for third-party diversion of glucose test strips into the U.S. from other nations.
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