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SimBioSys wins FDA clearance for MRI-based breast cancer recurrence tool

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SimBioSys announced on October 15, 2026, that the FDA had granted 510(k) clearance to TumorSight Risk. The FDA decision was dated September 25. The software combines routinely collected breast MRI, pathology and clinical information to estimate five- and ten-year recurrence risk for adult women with HR-positive, HER2-negative Stage I–IIIA breast cancer. It produces a score from 0 to 100 and a low-, intermediate- or high-risk category. The tool is intended to support—not replace—clinical judgment and other risk information. In a retrospective, multi-institutional validation study of 2,129 patients, people classified as high risk had 3.3 times the recurrence risk of those classified as low risk. Each 10-point score increase was associated with a 22% increase in relative recurrence risk. TumorSight Risk is built on SimBioSys’s TumorSight Viz platform and uses NVIDIA technology. It works with existing clinical data, so it does not require an extra scan or procedure. Sources: Si...

Estuary launches with $103M to advance kidney disease gene therapies

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City Therapeutics raises $200M in IPO as Frazier biotech SPAC lists

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OrbiMed raises $3B across two healthcare funds

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Lakefront sells cell therapy pipeline to Armed Cell

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NorthStar partners with Quarkmed to support Ac-225 drug filings in China

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Iambic raises $150 million in IPO to advance cancer drug pipeline

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AstraZeneca and insitro partner on AI-led liver and heart drug discovery

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Vanda puts social-anxiety drug program on hold after Phase 3 setback

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Verastem’s early KRAS drug results draw bold CEO claim

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Rakovina secures exclusivity for AI-optimized KT-5000 profile

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Shared barriers keep Leqembi and Kisunla uptake challenging

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Verastem’s VS-7375 posts early pancreatic cancer responses, setting up a KRAS rivalry

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