FDA Radiology AI Devices

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.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.