Healium Announces FDA Registration of Healium Clinical as a Class II 510(k)-Exempt Biofeedback Medical Device
May 21, 2026
FDA Registration Accelerates Healium Clinical’s Expansion into Healthcare Settings Nationwide
FDA Registration Accelerates Healium Clinical’s Expansion into Healthcare Settings Nationwide
The approval is expected to drive increased clinical adoption and support applications for regulatory approval in other markets.
Leo Cancer Care’s CE mark approval for Marie® signals a transformative shift in how radiotherapy is delivered across Europe.
The lightweight, at-home sensor records MJM, a validated biosignal for sleep evaluation.
According to Guardant, Guardant360 Liquid assesses a ‘100x wider’ genomic footprint to guide cancer treatment decisioning than its predecessor.
Sentante announced today that it received CE mark for its flagship endovascular surgical robot platform for treating stroke.
SYDNEY, May 18, 2026 /PRNewswire/ — SeeTreat’s ART.1-US software delivering automated adaptive decision support for every patient at every treatment is cleared for use in the USA. From today, US clinics with Varian or Elekta CT linear accelerators, will be able to access daily evaluations of radiotherapy dose to patients’ changing anatomy. With ART.1-US, clinical teams can now decide the right time for a new radiotherapy plan in 95+ seconds[1], and download supporting clinical documentation.
Galvanize Therapeutics announced today that it received FDA clearance for its Aliya EX generator for the surgical ablation of soft tissue.
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.