The Dublin-based firm is developing an array of artificial intelligence-derived tools to improve the efficiency of its digital pathology outsourcing service.

NEW YORK — Tosoh Bioscience said on Thursday that it has received 510 (k) clearance from the US Food and Drug Administration for its automated HLC-723 GR01 glycohemoglobin A1c (HbA1c) analyzer.

Called the RESULTS Act, the bill would use a third-party database to set Medicare payment rates and would delay price cuts and data reporting scheduled for 2026.

The Simplexa COVID-19/Flu A/B  & RSV Direct Kit is used for the detection and differentiation of infections with SARS-CoV-2, flu A/B, and respiratory syncytial viruses.

The Colorado firm is expanding its partnerships, outreach efforts, technology applications, and sales force for its oncology screening and monitoring test business.

The Netherlands-based company will develop a low-cost, rapid point-of-care test using its Visualization by Infrared PEptide Reaction (VIPER) technology.

Medicare Part B data show that of the 20 CPT codes seeing the largest increase in payments from 2022 to 2024, all are for molecular- or sequencing-based tests.

The firm's full and mini gastrointestinal panel tests can now be used with fecal swab samples to detect pathogen nucleic acids.

The certification applies to Gradientech's Class B QuickMIC GN AST panel for Gram-negative bacteria, along with the entire diagnostic platform.

The company's Dragonfly instrument uses a proprietary sample preparation method and isothermal amplification to diagnose a variety of infectious diseases.

The projects include the development of rapid diagnostic tests for tuberculosis, Strongyloides stercoralis, and malaria.

The companies will use the Phase I Small Business Innovation Research (SBIR) grant to support the development of a urine-based ELISA to inform treatment decisions.