Artificial Intelligence

Roche Gets FDA Clearance for Additional Alzheimer's CSF Assays, Enhancing Diagnosis and Treatment Decisions

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF assays (tTau) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) measure two biomarkers of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease....

Eko Health Launches CORE 500™ Digital Stethoscope with Heart Disease Detection AI and Advanced Features

Next-generation FDA-cleared medical device brings non-invasive heart and lung disease detection to healthcare professionals at the point of care ...

Techsomed to Field Evaluate Image-Guided Ablation Software with GE Healthcare's LOGIQ™ Ultrasound Systems at Leading US Clinical Sites"

Techsomed Ltd., the developer of BioTrace, an AI powered software platform for real time ablation zone imaging and treatment precision enhancement....

CXR-AID, Powered by Lunit, Approved for Reimbursement in Japan, Boosting Market Growth

Medical AI solutions, including CXR-AID, officially included in Japanese health insurance reimbursement as a management service fee of imaging diagnosis...

FDA Approves ImageBiopsy Labs' AI Software for Comprehensive Long Leg Radiograph Measurements

- ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The company previously FDA-cleared its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant and intends to expand to the US with further MSK-focused software solutions....