FDA Radiology AI Devices

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

SERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.

The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

The Intra-Operative Positioning System (IOPS®) is a surgical navigation tool that helps clinicians navigate catheters and guidewires during endovascular procedures. It uses pre-acquired 3D vascular imaging data combined with real-time electromagnetic tracking to display precise tip positioning, serving as an adjunct to fluoroscopy. This technology enhances procedural accuracy without making direct diagnoses.

The Pilot TLS system helps healthcare providers accurately position central venous catheters by real-time monitoring of the patient's cardiac electrical signals. This serves as an alternative to traditional chest X-ray or fluoroscopy confirmation methods, potentially reducing radiation exposure and speeding up catheter placement.

Loss of Pulse Detection is a software application from Fitbit designed to analyze pulse data collected by consumer wrist-worn devices to detect possible loss of pulse events. When such events are detected, it alerts the user with audio, visual, and haptic signals, and can prompt an emergency call if the user does not respond. This helps in early identification of critical cardiac events, improving patient safety by notifying potential emergencies.

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.

Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.