
FDA clears Glooko’s cloud-based insulin dosing platform
Ideating on Glooko’s existing EndoTool system, the cloud-based version is designed to support more scalable deployment across hospital settings.

Ideating on Glooko’s existing EndoTool system, the cloud-based version is designed to support more scalable deployment across hospital settings.

The assay enables ChLIA measurement of testosterone markers, delivering diagnostic capabilities for suspected male hypogonadism.

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.