The U.S. FDA has greenlighted two new modules for Siemens Healthineers’ AI-Rad Companion platform, giving radiologists new artificial intelligence (AI) tools to assist in interpreting magnetic resonance imaging (MRI) studies of the brain and prostate. The AI-Rad Companion Brain MR for Morphometry Analysis and AI-Rad Companion Prostate MR for Biopsy Support join earlier intelligent software modules for Chest CT.

Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.

The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.”

The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle.