The European Medicines Agency (EMA) has qualified PathAI’s AIM-MASH AI Assist as the first artificial intelligence tool to support the identification of inflammatory liver disease in biopsy samples for the enrollment of patients in clinical trials and the assessment of primary and secondary endpoints.
European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials
PathAI’s Tool Can Increase Reproducibility And Repeatability
With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

More from Clinical Trials
More from Policy & Regulation
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.