Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Butterfly Network, Mesa Laboratories, Pharmajet, Pleural Dynamics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Onward Medical, Masimo, Zai Lab.
Neuroone Medical Technologies Corp. expanded into treatment of chronic pain with a new U.S. FDA clearance for use of its Onerf system to treat trigeminal nerve pain. The system uses radiofrequency ablation to disrupt pain signals from the nerve to the brain.
Several cardiology societies in the U.S. have updated their guidelines for management of hypertension, which for the first time includes and endorsement of renal denervation (RDN). Two companies are poised to benefit from the news, including Medtronic plc with its Symplicity Spyral device and Recor Medical Inc., and its Paradise RDN system.
Better Medicine OÜ raised €1 million (US$1.16 million) in a pre-seed funding round for its AI platform, Bmvision Kidney, which uses deep-learning models to detect malignant kidney lesions. The funds will be used to accelerate the rollout of the software across Europe and prepare for U.S. FDA clearance.
AI and machine learning products have proven complicated for regulatory authorities across the globe, but entities in the business of conducting health technology assessments also have their hands full according to several sources.
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