FDA Radiology AI Devices

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.

The Analytic for Hemodynamic Instability (AHI) is a software device that analyzes ECG signals to monitor patients' hemodynamic status, detecting signs of instability defined by low blood pressure combined with high heart rate. It provides clinicians with frequent, updated alerts to increase vigilance for patients at risk of hemodynamic deterioration, serving as an adjunctive monitoring tool alongside other patient data to improve early detection and patient management in clinical settings.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.