The AMDI™ Mini Respiratory Panel delivers RT-PCR results in under 10 minutes, enabling clinical action in the Time of Care™
Oculogica announced earlier this month that it won FDA 510(k) clearance for the SNAP concussion test.
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.