FDA Radiology AI Devices

The SPECTRALIS HRA+OCT and variants by Heidelberg Engineering GmbH are non-contact ophthalmic imaging devices combining confocal laser-scanning ophthalmoscopy and spectral-domain optical coherence tomography (SD-OCT). They capture detailed cross-sectional and angiographic images of the eye, aiding clinicians in diagnosing and managing various ocular diseases such as macular degeneration, diabetic retinopathy, and glaucoma. These devices enhance visualization of ocular anatomy and vascular structures, improving clinical evaluation and patient care.

The Volta AF-Xplorer is a medical device that uses machine and deep learning algorithms to help clinicians annotate 3D anatomical and electrical maps of the human heart in real-time. It primarily assists in identifying regions within the atria that exhibit abnormal electrical activity during atrial fibrillation or atrial tachycardia, which can guide targeted catheter ablation procedures, improving patient outcomes.

The SKOUT system is an AI-powered software device that helps gastroenterologists detect potential colorectal polyps in real-time during colonoscopy procedures. It highlights suspected polyps on the endoscopic video feed to assist doctors in colorectal cancer screening and surveillance, improving detection accuracy without replacing clinical judgment.

The CT/MR Tandem and Ovoid Set by Varian Medical Systems is a gynecological brachytherapy applicator that is used to treat cancers of the uterus, cervix, paracervix, endometrium, and vagina via HDR brachytherapy. The device is designed to be compatible with CT and MRI imaging, helping clinicians accurately deliver radioactive sources for cancer treatment. It improves patient care by ensuring precise radiation placement and is safe for MR environments.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.

AeviceMD is a wearable, non-invasive electronic stethoscope that records lung sounds from pediatric patients. It stores these sound recordings securely on a cloud platform, allowing healthcare professionals to later review, compare, and analyze them to support clinical assessments. The system includes hardware sensors, docking station, mobile and web apps, and cloud analytics to facilitate longitudinal monitoring of lung sound data.

Second Opinion® Pediatric is an AI-driven software designed to assist dental clinicians in detecting caries in bitewing and periapical radiographs of patients aged 4 years and older. It uses machine learning to identify and visually overlay potential caries lesions on dental X-rays, helping clinicians with improved detection accuracy without replacing professional judgment.

The AT-Patch (ATP-C130/ATP-C70) is a wearable ECG monitoring device that records cardiac electrical activity for up to 14 or 7 days respectively. It collects ECG data from a patch worn on the patient's torso, which is then analyzed by software algorithms to detect arrhythmias and other cardiac events. A physician reviews this analysis to provide a report to help clinicians diagnose heart conditions, aiding in the management of symptoms like palpitations, dizziness, and fatigue.

Vscan Air is a pocket-sized, battery-operated ultrasound imaging system designed for use by trained healthcare professionals. It operates wirelessly with a mobile app and provides ultrasound images and measurements across many clinical areas including abdominal, cardiac, obstetrics, musculoskeletal, and vascular applications. The device incorporates AI features to enhance diagnostic accuracy and assist clinicians, such as automatic bladder volume measurement using deep learning, and real-time guidance for cardiac imaging.