Exagen Diagnostics Inc., of Vista, Calif., has agreed to pay slightly more than $653,000 to resolve allegations that it had paid specimen processing fees to physicians to induce those physicians to use Exagen’s lab tests.
Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Edwards Lifesciences, Jenavalve Technology, Theranica.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Curium, Diadem, Imeka, Johnson & Johnson, Magnus Medical, Memed, Piur, Quanterix, Quest, T2 Biosystems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, RF Medical, Ventric Health.
No matter how you look at it, guiding percutaneous coronary interventions to treat complex lesions with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) produces similar results in patients with complex lesions, a study presented Oct. 23 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco indicated.
The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
Phasev Inc. has raised $15 million in a funding round that will allow the company to further develop its machine learning (ML) technology that aims to revolutionize clinical trial design, execution and analysis. The funding round was led by Viola Ventures and Exor Ventures and included participation from Lionbird and a group of prominent angel investors.
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