Diagnostics & Imaging
SimBioSys TumorSight Risk
FDA-cleared prognostic software combining breast DCE-MRI data and clinicopathological factors to estimate five- and ten-year recurrence risk.
The Signal
Cleared under K260023 for adult women with HR-positive, HER2-negative, N0/N1, Stage I to IIIA breast cancer. Supports physician assessment, not diagnosis, treatment-benefit prediction or claims of reduced re-excision rates.
Company profileMore in Diagnostics & Imaging
Aidoc
AI software that flags acute abnormalities in medical imaging to assist radiologists.
View toolViz.ai
AI powered triage and care coordination platform for stroke, vascular, and cardiac emergencies.
View toolLunit
AI image analysis software for detecting cancer signs in mammography and chest x-rays.
View toolPaige AI
AI enabled pathology platform designed to assist pathologists in diagnosing cancer from tissue slides.
View tooliRhythm
Wearable continuous ECG monitoring service and clinical analysis platform for cardiac arrhythmia detection.
View toolPathAI
AI pathology tools designed to improve precision medicine and pathology analysis in clinical trials.
View tool