Nuralogix Corp.’s Anura health platform has expanded its capabilities to predict health risks using transdermal optical imaging (TOI) technology to include fatty liver disease (FLD), which affects an estimated quarter of the U.S. population. The platform uses facial blood flow patterns to provide medical-grade assessments of more than 30 health vital signs using any video-enabled device. Read More
The €13.8 million (US$15.25 million) Kiro SAS recently raised in its series A financing led by Sofinnova Partners will enable the company to further develop its artificial intelligence (AI) platform, which standardizes and analyzes laboratory test results, making them more relevant to doctors and easier for patients to understand. The funding will also allow the company to prepare the groundwork to enter the U.S. market where, Alexandre Guenoun, CEO at Kiro, told BioWorld, there is a huge “opportunity” for the AI platform following changes to regulations which require laboratories to communicate test results directly to patients. Read More
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product. Read More
The Ministry of Health and Prevention has just published a decree introducing the anticipated coverage by the National Health Insurance Fund of digital medical devices and remote medical monitoring activities. Read More
Largely underserved pediatric surgery patients in the U.S. could benefit from a new digital laparoscopic surgery solution said its developer Asensus Surgical Inc. Granted a pediatric indication by the U.S. FDA for the Senhance system in late March, the company plans to enter a market that has been largely ignored because of the difficulty performing digital laparoscopic surgery on smaller body patients. Read More
Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cedar Gate, Life Spine, Memed, Monteris Medical, Pison Technology. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerin Medical, Audere, Bioinnovation Institute, Boomerang, Ferring, Guardant, Humancyte, Lucid Diagnostics, Lumicell, Mend Nutrition, Opgen, Sapphiros. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Hemovent, Masimo, Neuspera, Rapidai, Syantra. Read More
