Medtronic announced on 19 October its robotic-assisted system Hugo has gained regulatory approvals in Japan, the third largest robotics market worldwide, and general surgery approval in the EU and Canada. A surgeon offered perspectives on Hugo versus Intuitive Surgical’s da Vinci surgical robot.
Medtronic plc received three significant regulatory approvals for its Hugo robotic-assisted surgery (RAS) system, expanding access into Europe, Canada and Japan, the company announced on 19 October.
Medtronic announced that Hugo RAS, which is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures, received...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
