Beyond its success in migraine and attention deficit hyperactivity disorder, Nu Eyne Co. Ltd. is advancing a portfolio of noninvasive, wearable trigeminal nerve stimulation devices across key three areas of neuromodulation, tissue regeneration and proliferation inhibition.
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
Quantalx Neuroscience Ltd. filed for protection of a system and method for the diagnosis of normal pressure hydrocephalus and prediction of patient response to ventriculoperitoneal shunting surgery treatment. The U.S. FDA granted the company’s Delphi-MD breakthrough device designation for these indications in May 2023.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Anaconda, Applaud Medical, Avvio, Calmwave, Innoblative Designs Inc., Jogo Health, KT Corp., Nference, Seastar, Sonde, Sumitomo Corp., Quest Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Globus Medical, Hyperfine, Subtle Medical.
The €10.2 million (US$11 million) that Bedal International NV recently closed in a funding round is “crucial” for the company’s continued growth and development, co-CEO Alexander Van Damme, told BioWorld. “The financing provides the necessary resources to scale up operations, enhance product development, and expand market reach, particularly in the competitive U.S. market,” he said.
The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
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