People with drug-resistant epilepsy have had few other options, but Neuropace Inc. appears on target to provide an alternative. The Nautilus trial of its responsive neurostimulation system for individuals with drug-resistant idiopathic generalized epilepsy showed a 77% reduction in generalized tonic-clonic seizures sustained over 18 months. Read More
Epiminder Ltd. raised AU$125 million (US$82.99 million) in its initial public offering on the Australian Securities Exchange to commercialize its Minder system, a long-term ambulatory electroencephalography monitoring device for epilepsy. Read More
The U.S. FDA’s clearance of Medtronic plc’s Hugo robotic-assisted surgery (RAS) system is certainly a boon for the company which is betting on the unit to be a key growth driver. While the soft tissue robotics market is dominated by Intuitive Surgical Inc.’s da Vinci system, the space is growing, and Medtronic has the scale, resources and market presence to make headway but there are also a plethora of smaller, versatile and cost-effective systems looking for a piece of the pie. Read More
A U.S. FDA advisory panel voted unanimously against approving Johnson & Johnson’s V-Wave Ventura shunt for heart failure patients not helped by medications. The circulatory panel voted emphatically 15-0 against use of the shunt for heart failure patients not helped by medications based on effectiveness and its benefit-risk profile. On the question of safety, the panelists did vote 9-6 in favor of the device. Read More
The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Acon, Asahi Kasei, Eyeyon Medical, Fize Medical, Helio Genomics, Lunit, Olympus, SS Innovations, Staar. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Resmed. Read More
