FDA Radiology AI Devices

The Eclipse Treatment Planning System (version 18.1) is a software tool designed by Varian Medical Systems to assist clinicians in planning radiation therapy for patients with malignant or benign diseases. It uses medical imaging to create a virtual patient model to simulate and optimize radiation dose distributions for external beam and internal radiation treatments, ensuring effective tumor targeting while minimizing damage to healthy tissues. This system includes features for proton therapy and advanced optimization algorithms to enhance treatment quality and delivery efficiency.

The Philips IntelliSite Pathology Solution 5.1 is a digital pathology system that automates scanning, managing, and viewing of glass pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It aids pathologists by providing high-resolution digital images of tissue slides for diagnostic review, enhancing the workflow for interpretation compared to traditional microscopy.

The PowerCube+ Series by GANSHORN Medizin Electronic GmbH is a medical device designed for professional healthcare settings to measure lung function in patients 5 years and older. It performs multiple pulmonary function tests such as Spirometry, Body Plethysmography, Lung Diffusion, Occlusive Resistance, and Respiratory Muscle Strength measurements. These tests help clinicians obtain detailed physiological parameters used to diagnose and monitor lung conditions. The device uses ultrasound technology for flow measurement, an air-tight chamber for body plethysmography, and gas analyzers to assess lung diffusion capacity. It supports electronic medical record integration, providing accurate and reliable data for respiratory assessment.

The HemoSphere Alta Advanced Monitoring Platform is an advanced medical monitoring system used primarily in critical care for adult and pediatric patients. It combines data from various catheters and sensors to continuously measure cardiac output, pressures, blood oxygenation, and derived hemodynamic parameters. The system provides clinicians with insights about cardiac function and patient status through integrated algorithms and a user-friendly interface, supporting decision-making in complex clinical scenarios.

The Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.

The HomeSleepTest (HST, HST REM+) by Somnomedics GMBH is a non-invasive, prescription device designed for home use to aid in the diagnosis of sleep disorders, including sleep-related breathing disorders. It records multiple physiological signals such as brain electrical activity (EEG), eye movements (EOG), muscle activity (EMG), oxygen saturation, heart rate, and snoring. The data is collected via frontal and mastoid electrodes and other sensors, then uploaded to a cloud platform for analysis by clinicians using specialized software. This helps physicians assess sleep quality and breathing disorders outside of hospital settings, improving patient comfort and accessibility to diagnostic testing.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.

DeepRhythmAI is a cloud-based AI software that analyzes two-lead ECG data to detect cardiac arrhythmias in adult patients. It integrates with ambulatory ECG devices like Holter monitors and cardiac telemetry systems to help healthcare professionals review and confirm arrhythmia diagnoses, providing supportive information alongside clinical knowledge.