{"version":1,"type":"story","url":"https://digestai.news/story/fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris","json":"https://digestai.news/story/fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris.json","markdown":"https://digestai.news/story/fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris.md","slug":"fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris","headline":"FDA clears SimBioSys’s TumorSight Risk for breast cancer recurrence risk","summary":"The tool covers **75 percent of U.S. breast cancer cases**, according to the company, and uses **proprietary spatial AI modeling** on existing MRI data without additional procedures or hardware.\n\nThe clearance follows a **blinded, multi-institutional retrospective study** of **2,129 patients** from Mayo Clinic, Emory University, Stanford Medicine, and Mercy Medical Cedar Rapids. The algorithm was trained on **1,133 samples** from six U.S. The tool integrates with **GE and Siemens MRI scanners** and is positioned as a complement to genomic assays, offering earlier risk insights.","keyPoints":["FDA cleared TumorSight Risk for hormone receptor-positive, HER2-negative breast cancer patients in Stage I–IIIA","Study of 2,129 patients showed high-risk patients had 3.3x greater recurrence risk than low-risk patients"],"whyItMatters":"This is the first FDA-cleared AI tool for breast cancer recurrence risk using MRI data, potentially shifting earlier care planning beyond genomic assays.","category":{"slug":"robotics","name":"Robotics & Physical AI","url":"https://digestai.news/category/robotics"},"entities":{"companies":["SimBioSys","Artera Inc.","GE","Siemens","Mayo Clinic","Emory University"],"models":["TumorSight Risk","TumorSight Viz","ArteraAI Breast"],"people":["Stacey Stevens","Matthew Goetz"]},"firstPublishedAt":"2026-10-15T12:46:13Z","updatedAt":"2026-10-15T12:46:13Z","sourceCount":1,"hasPrimarySource":false,"sources":[{"outlet":"Unite.AI","title":"SimBioSys Wins FDA Clearance for Breast Cancer Recurrence AI Tool","url":"https://unite.ai/simbiosys-wins-fda-clearance-for-breast-cancer-recurrence-ai-tool","publishedAt":"2026-10-15T12:46:13Z","type":"press","primary":false,"lead":true}],"sourceNotes":null,"discussions":[],"thread":null,"cite":{"text":"Digest AI, \"FDA clears SimBioSys’s TumorSight Risk for breast cancer recurrence risk\", 15 October 2026, https://digestai.news/story/fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris","publisher":"Digest AI","title":"FDA clears SimBioSys’s TumorSight Risk for breast cancer recurrence risk","datePublished":"2026-10-15T12:46:13Z","url":"https://digestai.news/story/fda-clears-simbiosyss-tumorsight-risk-for-breast-cancer-recurrence-ris"},"generatedBy":"Written by Digest AI's editorial model from the linked sources; the sources are the record.","license":"Headlines, digests and key points are written by Digest AI and may be quoted with a link to the story page. Linked articles belong to their publishers. Terms: https://digestai.news/terms#reuse"}