Sonomotion wins updated FDA nod for lithotripsy device for kidney stones, trial meets endpoints
May 14, 2026
SonoMotion announced today that the company picked up updated FDA clearance for its Break Wave lithotripsy platform.
SonoMotion announced today that the company picked up updated FDA clearance for its Break Wave lithotripsy platform.
IVDR-compliant PCR test supports detection of 11 clinically relevant gastrointestinal pathogens from 1 sample
The CE mark was granted based on data from retrospective studies in real-world early cognitive decline population.
Epineuron announced today that it received FDA 510(k) clearance for its Evala nerve stimulator technology.
The US Food and Drug Administration (FDA) has cleared Bayesian Health’s continuous artificial intelligence (AI)-driven sepsis monitor, making the device the first of its kind to achieve this milestone.
Siemens Healthineers announced today that the FDA cleared six new systems within its Artis interventional imaging portfolio.
Diabeloop announced today that it received CE mark approval for its latest automated insulin delivery (AID) platform, DBLG2.
Corvention announced today that it received FDA 510(k) clearance for its KardiaPSI balloon catheter device.
Handheld fingertip device delivers clinical-grade readings — no cuff, no calibration, no compromise.
The NMPA designation advances NHWD-870 HCI, an oral BET inhibitor for advanced thoracic NUT carcinoma, following Phase II data showing anti-tumour activity and survival benefit in a rare, aggressive cancer with limited treatment options.