Neurovalens wins FDA nod for weight management neurostim device
December 11, 2025
Neurovalens announced that it received FDA de novo approval for Modius Lean, its non-invasive neurotechnology for weight management.
Neurovalens announced that it received FDA de novo approval for Modius Lean, its non-invasive neurotechnology for weight management.
Flow Neuroscience’s at-home depression treatment device has become the first of its kind to be approved by the FDA.
Lumos Labs’ LumosityRx is positioned for use alongside other ADHD treatment modalities such as medication and therapy.
Ceribell (Nasdaq:CBLL) announced that it received FDA 510(k) clearance for its proprietary delirium monitoring solution.
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software.
Intuitive (NASDAQ: ISRG)+
announced today that the FDA cleared its da Vinci single port (SP) surgical robot for use in new types of procedures.
HeartBeam’s ECG software duplicates the 12-lead ECG approach undertaken in healthcare settings with electrodes to evaluate heart arrhythmias.
The assay is currently available in nations that recognise the CE Mark.
The ProVee System is a next-generation prostatic urethral stent designed to gently open up the obstructed prostate and relieve lower urinary tract symptoms associated with BPH
Medical Microinstruments (MMI) announced today that the FDA granted 510(k) clearance for its NanoWrist surgical robot instruments.