Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camber Spine, Saphetor, Think Surgical, Zimvie.
Paige AI Inc.’s partnership with Microsoft Corp., announced last September, appears to have paid off quickly, with a study published in Nature Medicine demonstrating that their jointly developed image-based artificial intelligence model, Virchow, detects 16 cancer types as well or better than tissue-specific clinical-grade models.
The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.
Magenta Medical Ltd. raised $105 million in financing that will go toward clinical trials and to secure U.S FDA approval for its Elevate system, the world's smallest heart pump. The substantial investment haul was “a vote of confidence” from the investor community for what the company is doing, David Israeli, CEO of Magenta told BioWorld.
The U.S. Patent and Trademark Office has provided updated guidance on the question of patent subject matter eligibility for inventions that rely on artificial intelligence, stating that a patent claim that does little more than recite an abstract idea is not subject-matter eligible.
A team of researchers from the University of Northumbria filed for protection of a flexible transdermal patch taht uses surface acoustic wave technology they believe offers distinct advantages over traditional transdermal patches.
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