FDA Radiology AI Devices

GI Genius is an artificial intelligence-based software device designed to assist endoscopists during colonoscopy. It analyzes live video images from standard white-light endoscopy in real time and highlights abnormal colonic mucosal lesions such as polyps and adenomas to aid detection. By providing visual markers on the video display, it helps clinicians identify lesions that might be missed, improving detection rates and supporting clinical decision making.

Oxehealth Vital Signs is a software device that uses optical cameras to noninvasively measure pulse rate and estimated breathing rate from video footage of patients. It facilitates vital sign monitoring in single-occupancy hospital rooms and care environments without physical contact, helping clinicians monitor patients effectively, especially those who do not require critical or continuous monitoring.

Chest-CAD is a computer-assisted detection software that uses machine learning to analyze adult chest X-rays. It identifies and highlights suspicious regions in various categories like cardiac, lungs, bones, and more, assisting physicians with concurrent reading during diagnosis. This helps improve detection accuracy and clinical workflow efficiency.

Precise Position is an AI-enabled accessory for Philips Incisive CT systems that assists technologists in accurately positioning patients before CT scans. It uses a ceiling-mounted camera to detect patient orientation, determine the scan range, and automatically center the patient's anatomy. This reduces positioning time and enhances accuracy for head, chest, abdomen, and pelvic CT imaging, ultimately improving imaging workflow and patient comfort.

EnsoSleep is a software medical device designed to analyze previously recorded physiological signals from sleep studies to automatically score sleep stages, detect arousals, leg movements, and various types of sleep-disordered breathing events. It supports both adult and pediatric patients and can be used for in-lab or home sleep tests. EnsoSleep assists clinicians by providing automated detection and scoring of events, which are then verified and can be edited by qualified clinicians to aid in diagnosing sleep disorders.

Transpara 1.7.0 is an AI software tool designed to assist physicians in interpreting breast imaging exams such as digital mammography and tomosynthesis. It uses deep learning algorithms to detect suspicious calcifications and soft tissue lesions, scoring their likelihood of malignancy to aid diagnosis and improve workflow. It processes images to highlight abnormal areas and provides exam-level cancer likelihood scores, supporting better identification of breast cancer indicators.

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

Overjet Dental Assist is a software designed to assist dental professionals by semi-automatically measuring bone levels on dental bitewing and periapical radiographs. It helps by automating the measurement process to support diagnosis and treatment planning but is not intended to replace full patient evaluation or diagnosis by professionals.

MEDO-Thyroid is a cloud-based software that uses machine learning to help radiologists evaluate ultrasound images of the thyroid. It assists in measuring thyroid lobes and nodules, supports diagnosis by providing volume measurements and TI-RADS classification, and generates reports, improving the efficiency and accuracy of thyroid image assessment for adult patients.

GI Genius is an AI-powered software and hardware system that helps doctors detect precancerous lesions like polyps in the colon during colonoscopy procedures in real-time. It enhances standard white-light endoscopy video by highlighting suspected lesions with superimposed green boxes, improving detection rates and potentially reducing colorectal cancer risk.