FDA Radiology AI Devices

MRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.

TeraRecon Neuro is an AI-powered image processing software that analyzes brain perfusion data from CT or MRI scans. It helps healthcare professionals visualize blood flow and other key parameters in the brain to aid diagnosis, treatment planning, and post-treatment evaluation by providing detailed parametric maps and 3D visualizations of brain tissues and vessels.

ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.

BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.

The Swoop Portable MR Imaging System is a bedside portable MRI device designed for producing images of the internal structure of the head when full diagnostic exams are not feasible. It uses advanced AI-based image reconstruction algorithms to enhance image quality with reduced noise and blurring, aiding clinicians in diagnosis at the point of care, such as emergency rooms or critical care units.

BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.

Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.

BriefCase by Aidoc Medical is an AI-powered software that analyzes non-enhanced head CT images to identify potential intracranial hemorrhage. It assists clinicians by flagging suspect cases and sending notifications with preview images to help prioritize patient care workflow. It operates alongside standard imaging interpretation without altering original medical images.