Cleveland Diagnostics has received ISO 13485:2016 certification for its IsoPSA Assay, supporting scaled U.S. commercialization following recent FDA approval for prostate cancer risk assessment.
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Diasorin has received FDA 510(k) clearance for its customizable LIAISON PLEX Gastrointestinal Flex Assay, allowing labs to select from 24 targets to tailor testing based on patient needs and operational priorities.
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The FDA has granted Breakthrough Device Designation to Valar Labs’ Vesta Bladder Risk Stratify Dx, the first AI-powered digital pathology prognostic test for bladder cancer.
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A multicenter clinical trial found the HelioLiver blood test detected early-stage liver cancer with 71.9% sensitivity, outperforming ultrasound’s 36.8%.
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BillionToOne has launched Unity Confirm, a non-invasive prenatal test that isolates fetal cells from maternal blood to confirm high-risk screening results, addressing the gap between NIPT and invasive diagnostics.
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