Surgical robots keep winning approvals, exoskeletons are heading home and hospital robots are leaving pilot wards. See what changed, then plan your clinic with The Humanoid Group.
FDA clears Wandercraft's Eve, a self-balancing exoskeleton for use at home
· Launch
The FDA cleared Eve, Wandercraft's self-balancing exoskeleton, for adults with spinal cord injuries who can operate its remote control. Users walk on level indoor floors and nearby patios with a trained companion, after a clinical assessment, fitting and five two-hour training sessions. US launch is set for September 17.
Why it matters: Exoskeletons are moving from clinic sessions to daily life, with assessment, training and a helper all required. THG Spec Cards list the space, assistance and support each model needs around it.
J&J's OTTAVA surgical robot, with arms built into the table, wins FDA authorization
· Policy
The FDA granted De Novo authorization to Johnson & Johnson's OTTAVA robotic system for general surgery procedures, including gastrectomy, gallbladder removal and appendectomy. Its four arms are built into the operating table, which J&J says takes 30 to 50 percent less space than boom- or cart-mounted systems. Launch starts with select US customers.
Why it matters: A new entrant gives hospitals more choice, but each system brings its own instruments, training and operating-room layout. Compare full cost of ownership and speak with hospitals already using it before shortlisting.
Foxconn's Nurabot nursing assistant moves from a pilot toward multi-hospital rollout
· Deployment
Foxconn's Nurabot nursing robot, which runs on Nvidia's physical AI software, finished field validation at Taichung Veterans General Hospital last year. It is now being introduced at more hospitals, long-term care facilities and overseas nursing schools, and digital-twin simulation is credited with cutting deployment time by 40%.
Why it matters: Robots for hospital wards are now rehearsed in simulation first. Before one arrives, map its route through corridors, elevators and doors; a THG Site Readiness Survey checks floors, power and Wi-Fi.
Regulating medical devices in the UK— Medicines and Healthcare products Regulatory Agency (GOV.UK). How medical devices are registered and marked for sale in Great Britain, including UKCA and CE marking rules.
Rehabilitation fact sheet— World Health Organization. WHO figures on the global need for rehabilitation, including the 2.4 billion people who could benefit from it.
Medical Devices Rules, 2017 (text and amendments)— Central Drugs Standard Control Organisation (CDSCO). CDSCO page holding the Medical Devices Rules, 2017 and later amendments, such as UDI and sales registration.