September Update: AI Launches & Approvals
📰 AI Is Coming for Your SoftwareDozens of clinical AI tools launched, earned approvals, or published results after Aug 26 and through September. Below are the specialty updates with clear facts and links, followed by a quick roll-up of new software launches.
☢Radiology & ImagingGE HealthCare introduces AI-enabled Voluson Performance ultrasound systems with FDA clearanceThe Voluson Performance 18 and 16 automate fetal anatomy annotations and adjust measurements in real time. Reported workflow data show exam times reduced by up to 65%, helping obstetric ultrasound teams increase throughput. Read moreTempus Pixel cardiac MRI platform gains FDA 510(k) for T1/T2 mappingThe latest Pixel software adds T1 and T2 mapping to cardiac MRI analysis, improving sensitivity to subtle myocardial tissue changes. Clearance expands the quantitative toolkit available to cardiothoracic imagers. Read more❤️CardiologyAI model estimates heart risk from routine mammograms (Heart journal)Researchers reported a deep-learning model that uses mammography features plus age to predict cardiovascular risk. In validation, performance was comparable to conventional risk scores, suggesting opportunistic CV screening from existing images. Read more🧬Oncology & PathologyDelphi-2M LLM forecasts multi-disease risk up to 20 years ahead (Nature)Developed by the German Cancer Research Center, Delphi-2M predicts risk for 1,000+ diseases using health records and lifestyle data. The study reports accuracy on par with, or better than, many single-disease models across conditions. Read more🩸Endocrinology / DiabetesRoche earns CE Mark for AI-enabled predictive alerts in mySugr with Accu-Chek SmartGuideThe integration issues glucose predictions up to 2 hours ahead inside the mySugr app and is rolling out across 13 European countries. The goal is earlier intervention and fewer nocturnal hypoglycemic events. Read more📝Clinical DocumentationTandem AI Scribe certified under EU MDR (CE Mark, Class I)Tandem’s documentation assistant is certified as medical-device software for generating clinical notes, confirming compliance with EU safety and performance requirements. This supports broader European deployment in care settings. Read more🚀New AI Software Launches
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🧠 Google Launches MedGemma for Healthcare App Developers 🔬 Breakthrough/Innovation Summary:Google has introduced MedGemma, a suite of open-source AI models designed to assist developers in building healthcare applications. Built on the Gemma 3 architecture, MedGemma includes a 4B multimodal model and a 27B text-only model, both optimized for medical text and image comprehension. 💡 Clinical/Business Impact:By offering fine-tunable and accessible models, MedGemma empowers developers to build AI...