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....
Next-generation FDA-cleared medical device brings non-invasive heart and lung disease detection to healthcare professionals at the point of care ...
Techsomed Ltd., the developer of BioTrace, an AI powered software platform for real time ablation zone imaging and treatment precision enhancement....
Medical AI solutions, including CXR-AID, officially included in Japanese health insurance reimbursement as a management service fee of imaging diagnosis...
- 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....