FDA Radiology AI Devices

TumorSight Viz is an automated radiological image processing software designed to assist clinicians by analyzing medical images for tumor-related information, potentially improving diagnosis and treatment planning for patients with tumors.

The Co-Ablation System with Sterile Co-Ablation Probe is a medical device that freezes and destroys solid tumors and abnormal tissue in various surgical fields using extreme cold temperatures. It is used in open, minimally invasive, or endoscopic procedures to treat cancers, benign tumors, skin lesions, and for pain management by freezing nerve tissue. The system works by delivering liquid nitrogen through a probe to freeze the target tissue under imaging guidance, allowing doctors to visualize the ice ball formation and control the treatment precisely for safer and more effective ablation.

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, and Halcyon are integrated tools designed to help clinicians manage, plan, and deliver radiation therapy treatment. The software supports radiation therapy plan management and adaptive treatment planning, while the radiotherapy systems deliver precise radiation treatment using image guidance to treat lesions and tumors anywhere in the body. These tools aim to improve the accuracy and effectiveness of radiotherapy for patients, including adults and pediatric patients.