FDA Radiology AI Devices

The Edison System is a non-invasive focused ultrasound device designed to mechanically destroy liver tumors using a non-thermal process called histotripsy. Integrated with diagnostic ultrasound imaging, it assists clinicians in precisely targeting and treating liver tumors without surgery, helping to improve liver cancer patient outcomes.

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.

The SurgiCount+ System by Stryker Instruments is a multifunctional software application designed to assist clinicians in estimating blood loss during surgery by analyzing images of used surgical sponges. It uses AI algorithms to estimate hemoglobin mass and blood volume on sponges and incorporates RFID technology to count and locate surgical sponges, improving surgical item management and patient safety.

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 MIMOSA Imager is a cordless, non-contact tissue oximeter that estimates and maps oxygen saturation in superficial tissue. It captures spatially-resolved images using visible and near-infrared light and presents tissue oxygenation as a heat map on a connected Android device. This helps clinicians monitor circulatory or perfusion status in patients, especially for skeletal muscle and suspected compromised circulation.

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.

The Triton System is a medical software application designed to assist surgical teams by estimating the amount of blood loss on used surgical sponges through image analysis. It runs on an iPad and uses validated hardware and software to calculate hemoglobin mass and blood volume, helping clinicians manage bleeding and surgical sponges more effectively during operations.