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 ...

Panakeia publishes landmark clinical validation showing AI can deliver rapid molecular profiling for colorectal cancer Largest real-world, blinded, multi-site validation of AI molecular profiling from ...

SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals CRYSTAL LAKE, Ill.--(BUSINESS WIRE)-- AptarGroup, Inc. (ATR), a global leader in drug and consumer product ...

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 ...

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 ...

Deep-Learning Model for Real-Time Prediction of Recurrence in Early-Stage Non–Small Cell Lung Cancer: A Multimodal Approach (RADAR CARE Study) Within 126 QPOP cases, 105 (52 B-NHL and 53 NK/T-NHL) ...

Study demonstrates comparable performance between wireless, patch-based Onera Sleep Test System and in-lab polysomnography for sleep staging and respiratory event detection. EINDHOVEN, ...

Patients with a lung neoplasm, NSCLC histology, and treatment information in their notes were selected from a repository of over 27 million patients. From these, 200 were randomly selected for this ...

From 28 April, IVDs used clinical trials will be subject to an upfront assessment by the MHRA as part of a Clinical Trial of ...