Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Meditrina, Owlet, Profound.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascensia Diabetes Care, CB Medical, GE Healthcare Technologies, Medis Medical Imaging Systems, Nanovibronix, Optiscan Imaging, Paindrainer, Realheart, Reveal Genomic, Senseonics, Valcare Medical.
A pair of co-published filings from Naples, Fla.-based Aerwave Medical Inc. describe apparatus and ultrasound-based methods for bronchial denervation, ablating smooth muscle or goblet cells, and emphysematous tissue remodeling in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease.
The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.
Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.
Two-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that there is a significant clinical advantage in using its Dynamx coronary drug-eluting bioadaptor system over Medtronic plc’s Resolute Onyx drug-eluting stent in patients with coronary artery disease.
Data from the transcatheter valve and vessel trial showed that percutaneous interventions in patients with aortic stenosis and coronary disease resulted in significantly lower mortality rates than those receiving surgical treatment.
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