Avenda Health AI Prostate Cancer Planning Software
Avenda Health, Inc.The Avenda Health AI Prostate Cancer Planning Software is an AI-driven tool that assists physicians by segmenting prostate MR images, evaluating and quantifying lesions, and planning diagnostic or interventional procedures such as biopsies or tissue ablation. It provides a cancer probability map and confidence scores to help clinicians accurately characterize prostate cancer lesions, improving workflow efficiency and decision making in prostate cancer care.
Intended Use
An artificial intelligence-based decision support software adjunct to review of MR prostate images and biopsy findings, supporting segmentation, lesion evaluation, quantification, documentation, and pre-planning for diagnostic or interventional prostate procedures.
Technology
AI-powered software including prostate MRI segmentation, lesion contouring tools, and simulated interventional tool placement, designed as a cloud-based web platform that exports planning data in DICOM and other formats to integrate with clinical systems.
Performance
Software verification, validation, usability testing, standalone performance testing for segmentation and lesion contouring against ground truth datasets, and a multi-reader multi-case study demonstrating improved reader sensitivity and specificity in lesion contouring.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/6/2022
5 months - 2
FDA Approval
11/22/2022
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