FDA Radiology AI Devices

Cleerly ISCHEMIA is an AI-based software tool that analyzes coronary CT angiography images to help clinicians detect likely ischemia in coronary vessels. It works as an add-on to Cleerly Labs software, providing a non-invasive decision support tool to assess the functional significance of coronary artery disease, aiding patient management alongside traditional diagnostic methods.

The Withings Scan Monitor 2.0 is a smart scale device that records a two-channel electrocardiogram (ECG) when a user stands on it and holds a handle. It analyzes the ECG data using AI algorithms to detect normal rhythms and atrial fibrillation, and displays results on the device and a mobile app, helping patients and clinicians monitor heart conditions conveniently at home or clinical settings.

The Dreem 3S is a wearable headband device that uses EEG electrodes and a 3D accelerometer to record brain electrical activity and movement during sleep. It applies an artificial neural network to automatically analyze and classify sleep stages, providing clinicians with detailed reports of patients' sleep patterns to aid in sleep assessment at home or in healthcare settings.

Viz HCM is a machine learning-based software designed to analyze 12-lead ECG recordings to detect signs of hypertrophic cardiomyopathy (HCM). It helps clinicians identify patients who may have HCM and need further clinical follow-up, supporting early detection though not replacing full diagnostic evaluation. The system includes an ECG analysis algorithm and a mobile app to present results, improving screening in routine cardiology care.

AusculThing ACC is an AI-powered decision support software that analyzes heart sounds recorded by an electronic stethoscope to help healthcare providers distinguish between normal and abnormal heart murmurs. It provides instant, automated analysis and visual and acoustic feedback to support clinical evaluation in both adult and pediatric patients.

EyeArt v2.2.0 is an AI-based software device designed to automatically detect more than mild and vision-threatening diabetic retinopathy in retinal fundus images. It assists healthcare providers by analyzing images captured from specific retinal cameras and providing diagnostic screening results to help identify retinal disease in adults with diabetes, facilitating early detection and treatment.

NeuroRPM is a software application for the Apple Watch that uses machine learning to analyze motion sensor data to quantify motor symptoms like tremor, bradykinesia, and dyskinesia in adult Parkinson's disease patients. It helps clinicians remotely monitor symptom presence every 15 minutes, supporting both clinic and home use for improved patient management.

Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that processes cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, a critical measure of heart function. It helps clinicians quickly and accurately evaluate cardiac health by analyzing ultrasound video clips, selecting the best quality views, and calculating ejection fraction with confidence metrics. This supports clinical decision-making in adult cardiac evaluations.

The Belun Sleep System BLS-100 is a wearable device designed for adult patients suspected of sleep apnea. It consists of a sensor ring worn on the user's index finger overnight to collect biophysical signals such as oxygen saturation and pulse, which are then analyzed by AI-powered software to help healthcare professionals assess the severity of sleep-related breathing disorders in both clinical and home settings.

Brainomix 360 e-ASPECTS is an AI-powered software that analyzes non-contrast CT brain scans to assist clinicians in detecting and characterizing ischemic brain tissue injuries, particularly in cases of acute stroke caused by MCA or ICA occlusions. It automatically provides an ASPECTS score, highlights affected brain regions, and visualizes voxel contributions to the score, helping clinicians make timely and more accurate assessments to guide stroke treatment.