This paper outlines the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative ?method-centric? software platform, designed for the analyst or operator, to electronically execute and man-age quality control testing protocols and production batch records, yielding significant reductions in overall product release cycle time.
FDA Grants Breakthrough Status to AI-Enhanced GC-MS Device for Bladder Cancer Detection
July 1st 2025A new cancer detection test to analyze volatile organic compounds through urine analysis, was granted the Breakthrough Device Designation status by the U.S. FDA. The system, which is built on gas chromatography–mass spectrometry (GC–MS) and proprietary AI, generates real-time cancer risk scores.
Researchers Explore Comprehensive Modelling Approach for Liquid-Liquid Chromatography
June 30th 2025Scientists from the Technical University of Munich and Lund University explored the use of new models for liquid-liquid chromatography based off pre-existing procedures for liquid-liquid extraction.