Distalmotion announced today that it received FDA 510(k) clearance for its Dexter surgical robot in a range of gynecology procedures.
Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children.
SurGenTec announced today that the FDA cleared its ION-L lumbar facet fixation system for degenerative disc disease (DDD).
Wave’s MeRT platform records individual patient brain data to tailor transcranial magnetic stimulation (TMS) therapy for PTSD treatment.
The clearance supports decentralized urine sample collection for molecular STI testing using Roche’s cobas platforms.
Siemens Healthineers announced that its first China-made dual-source photon-counting CT (PCCT), the NAEOTOM Alpha.Pro, has received market approval from China’s National Medical Products Administration (NMPA).
ANNE One captures ECG, heart rate, respiratory rate, SpO₂, pulse rate, skin temperature, body position, activity, and falls.
Penumbra (NYSE:PEN) announced today that it received FDA clearance for its Thunderbolt thrombectomy platform for stroke.
Subtle Medical has announced FDA clearance for SubtleHD(CT), an AI-powered image enhancement solution designed to reduce noise and improve low contrast detectability across CT imaging
The planned trial is expected to include 300 participants across two treatment arms.