FDA Radiology AI Devices

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.

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

XBeam (v2) is a software tool designed to calculate and validate the radiation dose or monitor units needed during external beam radiation therapy. It supports treatment planning for superficial and orthovoltage radiotherapy systems made by Xstrahl. By accurately calculating treatment parameters like beam-on time and dose, it helps ensure patients receive the prescribed radiation safely and accurately. The software is intended for use by trained medical physics professionals to improve the quality assurance of radiation treatments.

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.

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.