Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Hemovent, Masimo, Neuspera, Rapidai, Syantra.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cedar Gate, Life Spine, Memed, Monteris Medical, Pison Technology.
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.
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.
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.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Bio-Techne, Bracco Imaging, Dexcom, Excellus Communications, Fresenius, Livecare, Lunaphore, Quest Diagnostics, Radiopharm, Sonothera, Terthera.
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