Products regulated as medical devices: instruments, implants and equipment, the software that runs them, and software that qualifies on its own as Software as a Medical Device.
6 companies · 6 products
Surgical robotics company whose modular Versius system, and its second-generation Versius Plus, are used for minimal access surgery.
Surgical Technology · Based in United Kingdom
Pediatric monitoring company whose sock-worn sensors report an infant's pulse rate and oxygen level to a phone app, sold over the counter as Dream Sock and on prescription as BabySat.
Wearables · Based in United States
Dialysis technology company whose Tablo system combines water purification and dialysate production in one console, connected to electronic records and a data platform, cleared for use from hospital to home.
Medical Devices · Based in United States
CMR SurgicalSecond-generation modular surgical robot from CMR Surgical, cleared by the FDA in December 2025 under 510(k) K252111.
Surgical TechnologyDevicePrescription pulse oximeter worn as a sock, for infants who could benefit from additional monitoring at home under a physician's supervision.
Remote Patient MonitoringWearableiOS
Outset MedicalHemodialysis system that combines water purification and on-demand dialysate production in one console, connected to electronic medical records and a data platform, cleared by the FDA for use from hospital to home.
Medical DevicesDeviceWeb
