Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical results that demonstrated safety and functionality. Read More
Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being. Read More
Nexgel Biotech Co. Ltd. and CG Bio Co. Ltd. agreed to co-develop a thermosensitive polyphosphazene hydrogel-based long-acting drug delivery platform through a new collaboration agreement signed Oct. 31. Read More
The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a strong element of retroactivity to the QMSR. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avisi, Avita, E2, Neurosigma, Reset, Viz.ai. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Becton Dickinson, Brainsway, Lungpacer, Revbio, Sensus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Berry Genomics, Pacbio. Read More
