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BioWorld - Wednesday, May 31, 2023

510(k)

Home » Topics » Regulatory » 510(k)
  • Graymatters health patient using prism for ptsd along with prism
    March 29, 2023
    By Shani Alexander

    Graymatters Health gets FDA clearance for digital therapy for PTSD

    The U.S. FDA granted Graymatters Health Ltd. 510(k) clearance to market Prism for PTSD, a non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD).
  • Bot image scan prostatid
    March 28, 2023
    By Annette Boyle

    Bot Image’s AI scores an FDA hat trick with clearance to diagnose, detect and monitor prostate cancer

    The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
  • Elekta unity software
    March 17, 2023
    By David Godkin

    FDA clears major upgrade to Elekta’s MR-Linac system

    Elekta AB received U.S. FDA clearance for what it called a “groundbreaking upgrade” of its MR-Linac platform which can continuously calculate the movement of a tumor anywhere in the body. The company said the Elekta Unity’s comprehensive motion management platform provides clinicians with enhanced, adaptive radiation therapy workflow to track moving organs such as the prostate, liver and pancreas.
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