The FDA has cleared its first over-the-counter wearable blood sugar tracker, with Dexcom’s slimmed-down Stelo continuous glucose monitor.
Related: Orthobond wins FDA de novo approval...
SpineX has closed recruitment for a clinical study investigating its neuromodulation device to treat urinary incontinence.
Data from the trial, which began in May 2022,...
Spirair has secured 510(k) clearance for its SeptAlign system from the US Food and Drug Administration (FDA) for its use in the mechanical correction...
Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform.Clearance covers soft tissue manipulation to perform microsurgery....
Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million.Belfast, Northern Ireland-based Neurovalens designed...
Kelyniam Global and Finceramica Faenza have announced the Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system to...
The US Food and Drug Administration (FDA) has granted marketing authorisation for Prenosis’ AI tool Sepsis ImmunoScore, to diagnose sepsis.
This authorisation, achieved through the...
The US Food and Drug Administration (FDA) has granted clearance for Affinity Biosensors’s LifeScale AST system, a diagnostic tool for rapid antibiotic susceptibility testing...
