FDA Radiology AI Devices

SleepStageML is a software-only medical device that uses AI to automatically analyze EEG signals from sleep studies (PSG recordings) to identify different sleep stages. It assists qualified clinicians in diagnosing sleep quality and sleep disorders in adult patients by providing automated, software-generated sleep stage annotations that clinicians can review and verify.

Rapid ASPECTS (v3) is a software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. It automatically analyzes certain brain regions to generate an ASPECT Score, which helps characterize ischemic damage. This tool supports radiologists by providing standardized, AI-derived scores and annotated images, facilitating accurate and consistent stroke assessment to inform treatment decisions.

The CLEWICU System is a software platform that uses AI machine learning models to predict the likelihood of future hemodynamic instability in adult patients in various hospital critical care units. It integrates patient data from electronic health records and monitoring devices to help clinicians assess a patient's risk of clinical deterioration or stability, providing valuable physiological insights as an aid to clinical judgment.

DermaSensor is a handheld device combined with a base unit that uses optical spectroscopy and an AI/machine learning algorithm to analyze suspicious skin lesions and assist physicians, especially those not trained as dermatologists, in deciding whether a patient should be referred to a dermatologist. It provides a classification indicating whether to monitor the lesion or investigate further, helping clinicians detect common skin cancers earlier and more accurately.

Fibresolve is a software device that analyzes lung CT images using deep learning to identify patterns suggestive of idiopathic pulmonary fibrosis. It provides a binary output to assist clinicians in diagnosing fibrotic lung disease, serving as an adjunct tool in the diagnostic workflow especially before invasive testing, helping to improve early detection and referral for appropriate clinical discussion.

BrainSee is software that helps clinicians predict whether patients aged 55 to 95 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer's disease dementia within 5 years. It uses standard brain MRI scans along with patient demographics and cognitive test scores to generate a similarity score indicating the likelihood of progression. This tool provides supplemental prognostic information to aid clinical decision-making but is not a standalone diagnostic device.

Tyto Insights for Wheeze Detection is an AI-powered software tool that analyzes lung sounds recorded by the FDA-cleared Tyto Stethoscope to automatically detect the presence of wheezing. This helps clinicians by providing decision support in respiratory assessments for adults and children aged 2 years and older. It offers clear positive or negative wheeze detection results through a web interface accessible to healthcare providers and patients, improving remote and point-of-care lung sound evaluation.

Transpara Density 1.0.0 is an AI-powered software designed to assist healthcare professionals in assessing breast tissue composition from digital mammography and tomosynthesis images. It automatically calculates volumetric breast density, breast volume, and categorizes breast density according to ACR BI-RADS 5th Edition. This helps radiologists make informed decisions about breast cancer screening and diagnosis.

LOGIQ Totus is a comprehensive diagnostic ultrasound system designed for use by trained healthcare professionals. It offers imaging, measurement, display, and analysis for a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports multiple ultrasonic imaging modes and integrates AI-enabled features such as auto preset selection and auto abdominal color assistant to improve efficiency and accuracy in clinical settings.

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.