FDA Radiology AI Devices

TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.

UroNav 4 is a medical image processing and navigation system that helps clinicians plan and guide biopsy and soft tissue ablation procedures, especially for the prostate gland. It fuses and registers 2D and 3D ultrasound images with other imaging modalities like MRI to provide real-time image guidance using electromagnetic tracking. This enhances precision in navigating interventional instruments, improving clinical outcomes in minimally invasive procedures.

The Ingenia MR system family by Philips includes 1.5T and 3.0T MRI scanners that produce detailed cross-sectional and spectroscopic images of the body. It helps physicians diagnose and plan treatments by providing high-quality images of the head, body, and extremities. The system features an AI-based image reconstruction software called SmartSpeed Precise, which improves image sharpness and signal-to-noise ratio while reducing artifacts, enhancing image quality without changing intended use or safety.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.

The PhysCade System is a specialized AI-driven software and hardware platform designed to analyze and visualize intra-cardiac electrophysiological data collected during heart rhythm studies. It helps clinicians by providing detailed maps identifying early activation sites and other features of interest in the heart during arrhythmia procedures. This assists physicians to make more informed clinical decisions during electrophysiology procedures, improving patient care for those with heart rhythm disorders.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.

The Swoop® Portable MR Imaging® System (V2) by Hyperfine, Inc. is a portable, ultra-low field MRI device designed to image the internal structure of the head. It is intended for use in clinical settings where full diagnostic MRI exams may not be practical, providing clinicians with images that aid in diagnosis. The system features advanced image reconstruction using deep learning to optimize image quality, enhancing visualization while being convenient and fast to deploy at the point of care.

AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.

BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.

Opulus™ Lymphoma Precision is an AI-powered software tool designed to help physicians analyze whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume. This supports physicians by reducing the manual workload and assisting in more efficient interpretation of PET/CT images, although final decisions remain with the radiologist.