FDA Radiology AI Devices

The OPUSWAVE Dual Sensor Imaging System is a medical device that uses Optical Coherence Tomography to capture detailed images of cardiovascular structures. It helps clinicians by providing high-resolution imaging to assist in diagnosis and treatment of cardiovascular conditions.

The SPECTRALIS with Flex Module is an advanced eye imaging device designed for non-contact visualization of the posterior segment and vasculature of the retina and choroid in adults and pediatric patients, including those in supine (lying down) position. It helps ophthalmologists detect and monitor various eye conditions by providing high-quality images of eye structures, enabling improved diagnosis and management.

The Notal Vision Home OCT System is an AI-based home use device that enables patients with neovascular age-related macular degeneration (NV-AMD) to self-image their eyes at home using Optical Coherence Tomography (OCT). It captures detailed images of the retina, segments and quantifies hypo-reflective spaces associated with fluid build-up, and securely transmits data for physician review between scheduled clinic visits. This allows more frequent monitoring of eye disease progression without replacing standard clinical examinations.

The OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical are advanced OCT imaging systems designed for use in cardiovascular catheterization labs. Paired with compatible Dragonfly imaging catheters, these devices provide detailed imaging of coronary arteries and physiological measurements to help physicians assess coronary lesions and determine the need for intervention.

The OTIS 2.1 Optical Coherence Tomography System is a medical imaging device that provides high-resolution, two-dimensional, cross-sectional real-time images of excised human tissue microstructures. It uses non-ionizing optical radiation to create detailed subsurface images, aiding clinicians in evaluating tissue samples. The device automates image acquisition and review, allowing users to identify and annotate regions of interest efficiently, supporting clinical decision-making and improving visualization during tissue evaluation.

The NvisionVLE Imaging System by NinePoint Medical, Inc. is a high-resolution optical coherence tomography (OCT) imaging device designed to visualize tissue microstructures, especially in the esophagus. It uses a specialized probe and advanced imaging software to provide clinicians with real-time, cross-sectional images of tissue, enhanced by AI-based segmentation to color-highlight important features. This helps clinicians better review and mark areas of interest in the tissue during evaluation, aiding in diagnosis and treatment planning.