CMR Surgical Ltd. hopes to soon gain U.S. FDA 510(k) clearance for its Versius Plus surgical robotic system to bring it to the U.S. market amid rising demand for robotic surgery. Although the company’s original Versius system received FDA clearance in 2024 for use in cholecystectomy in adults, CMR waited to bring the enhanced Versius Plus model to market instead. “I have such a respect for the U.S. market that the last thing that I would do is to enter a market with a product that is outdated,” Massimiliano Colella, CMR CEO told BioWorld. Read More
Abbott Laboratories announced a recall of Freestyle Libre 3 and Libre 3 Plus sensors used in continuous glucose monitors after receiving reports of more than 700 injuries and seven fatalities that may be associated with the sensor malfunction. The company did not describe the nature of the malfunction let alone a root cause, but said the affected product comes from only one of three production lines, and thus it expects no shortages associated with the recall. Read More
A precision medicine diagnostic system developed by Diag-Nose Medical Pty. Ltd. could potentially transform the management of chronic respiratory diseases. Co-founders Eldin Rostrom, David Yen, Brian Wang and Josie Xu set out to explore why patients with similar respiratory symptoms respond so differently to treatment. Read More
The U.S. Centers for Medicare & Medicaid Services released the 1657-page final rule for inpatient payment for calendar year 2026, a document chock full of important policy decisions including a renewed call for elimination of the inpatient-only list. Read More
At the 2025 annual meeting of the Society for Neuroscience in San Diego this week, Catherine Woolley’s plenary lecture was an unusual combination of debunking and affirming the importance of sex differences in the brain. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dariohealth, Echo IQ, Inspiremd, Jenavalve. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: C2N Diagnostics, Clearside, Danaher, DK Healthcare, Fize, Leica Biosystems, L7 Informatics, Nano-X Imaging, Pathkeeper, Polarean, Premier. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Ceribell, Transmural Systems, YD Bio. Read More
