FDA Radiology AI Devices

DentalMonitoring is a medical software device that uses AI to analyze pictures of a patient's mouth taken via smartphone and proprietary hardware. It helps dental professionals remotely monitor orthodontic treatments by assessing oral hygiene, soft tissue, dental conditions, alignment, and occlusion. It provides 2D and 3D monitoring capabilities to track treatment progress safely and non-invasively.

The Genius Digital Diagnostics System with the Genius Cervical AI algorithm is an AI-powered digital imaging system designed to scan, analyze, and help interpret ThinPrep Pap test slides for cervical cancer screening. It identifies clinically relevant cellular objects and presents them in an easy-to-review format for cytologists and pathologists, improving diagnostic sensitivity while assisting in patient management.

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.

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.

Paige Prostate is an AI software device by Paige.AI designed to assist pathologists in detecting prostate cancer in digitized pathology slides from needle biopsies. It analyzes whole slide images scanned from H&E stained tissue samples and identifies areas most suspicious for cancer, helping pathologists to focus their review and improve diagnostic accuracy. It serves as an adjunct tool and supports clinicians in making more accurate prostate cancer diagnoses.

GI Genius is an AI-powered software and hardware system that helps doctors detect precancerous lesions like polyps in the colon during colonoscopy procedures in real-time. It enhances standard white-light endoscopy video by highlighting suspected lesions with superimposed green boxes, improving detection rates and potentially reducing colorectal cancer risk.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.

EyeBOX is a device that uses an eye-tracking camera and software to measure and analyze eye movements as an aid in assessing concussion within one week of head injury for patients aged 5 to 67. It provides clinicians with a score indicating possible brain injury based on abnormal eye movement patterns, helping supplement traditional neurological assessment.

IDx-DR is an AI-based retinal diagnostic software designed to automatically detect more than mild diabetic retinopathy in adults with diabetes using retinal fundus images acquired with a specific fundus camera. It helps clinicians by providing screening results that indicate the presence or absence of disease, enabling timely referral and treatment to prevent vision loss.

The BrainScope Ahead 100 is a portable EEG-based device designed to assist physicians in evaluating patients with mild traumatic brain injury. It analyzes brain electrical activity to help decide if a head CT scan is needed, potentially reducing unnecessary CT scans and radiation exposure. The device processes EEG data using AI-driven algorithms to classify patients based on the likelihood of structural brain injury visible on CT.