Healthcare Dive

AI devices with no clinical validation tied to more recalls, study finds

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...
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Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology

Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3% Natera’s study is the largest clinical validation of a fetal RhD ...
Business Wire

Landmark Study Demonstrates Clinical Validation of Aiberry AI-Powered Mental Health Assessments

Rigorous study by The University of Texas at Austin demonstrates Aiberry is clinically equivalent to the current gold standard for mental health assessment SEATTLE--(BUSINESS WIRE)--Aiberry®, a ...
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Lucid Diagnostics' ESOGUARD BE-1 Prospective Multicenter Clinical Validation Study of EsoGuard® Esophageal Precancer Testing Accepted for Peer-Reviewed Publication

Publication, which once again demonstrates strong EsoGuard performance in a screening population, completes Lucid's clinical evidence package for submission to formally seek Medicare coverage The ...
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Real-World Validation of the Purity Independent Subtyping of Tumors Classifier for Informing Therapy Selection in Pancreatic Ductal Adenocarcinoma

Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving Palbociclib: Biomarker Results From POLARIS Study FOLFIRINOX (FFX) and ...