GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.

A collaborating team of researchers from the U.K.’s University College London and the Incliva Biomedical Research Institute in Valencia, Spain, filed for protection of a machine learning model called AMMON-OHE to predict occurrence of overt hepatic encephalopathy in patients with cirrhosis of the liver.

Noul Co. Ltd.’s Micro-Intelligent Laboratory, an artificial intelligence-powered diagnostic system, demonstrated superiority over microscopic diagnosis for malaria in a study presented at the 2024 International Congress for Tropical Medicine and Malaria.

In what represents its first patenting, Roseville, Minn.-based Iveacare Inc. provides insights as to what its first therapeutic target will likely be since the developer of neuromodulation therapy devices emerged from stealth mode in April 2024 with the closing of $27.5 million series A financing.

Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.

The first patenting from Encephalogix Inc. details its development of platform that uses machine learning and AI to analyze EEG data that is typically ignored.

The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.

Germitec SA received U.S. FDA de novo clearance for Chronos, its chemical-free, ultraviolet-C-based disinfection device for endocavitary and external ultrasound probes. The technology will help to protect patients and aid health care professionals in tackling cross-contaminations in U.S. hospitals, Vincent Gardès, CEO of Germitec, told BioWorld.

Grail Inc.’s multi-cancer early detection test, Galleri, preferentially screens for aggressive prostate cancer, addressing concerns about overdiagnosis and subsequent overtreatment of indolent cancers, a study published in JCO Precision Oncology demonstrated.

A magistrate judge for a U.S. district court has recommend that Abbott Laboratories receive $54 million in damages for third-party diversion of glucose test strips into the U.S. from other nations.