More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31. Read More
Abbott Laboratories Inc. announced U.S. FDA clearance for its next-generation Freestyle Libre 3 continuous glucose monitor (CGM) system for people aged 4 years and older with diabetes. Accuracy of the sensor was evaluated in a non-randomized, multicenter, single-arm study with 100 people on intensive insulin therapy (95, aged 6 years and older). Results from the pivotal trial were released May 31, showing it is the first CGM to demonstrate a mean absolute relative difference (MARD) below 8%, indicating it will be one of the most accurate sensors on the market. Read More
Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states. Read More
The U.S. Court of Appeals for the Federal Circuit has ruled again on the appointments clause questions evolving from a patent dispute between Arthrex Inc. and Smith & Nephew Inc., this time in connection with a former acting director of the Patent and Trademark Office (PTO). Read More
Less than three years after unveiling the first Sonovein device, Theraclion SA is launching its CE-marked, third-generation platform, Sonovein HD. This represents a new generation of robotics platform for noninvasive treatment of varicose veins. The new version integrates the acquisition and analysis of technical data during the procedure. Read More
The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Filterlex, Lucence, Orthofix, Sight Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abingdon Health, AMD Medicom, Angle, Blue Note Therapeutics, Deepverge, Dexcom, Element Biosciences, Evotec, Histosonics, Innovation Zed, Insulet, Midlantic Urology, Oncohealth, Rignerand, Seqwell, Snaq, Solaris Health, Vitacore. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Embody, Si-Bone, Stryker, Volition. Read More
