FDA Radiology AI Devices

The Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.

AISight Dx is a software-only, web-based digital pathology image viewing and management system designed to aid pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It supports images from scanners such as the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX. The software allows pathologists to zoom, pan, measure, and annotate whole slide images to assist in primary diagnosis while ensuring image quality through built-in quality controls.

The Neuralytix iD3 System is a surgical nerve stimulator and locator that helps surgeons find and monitor motor nerves during surgery by measuring muscle responses to electrical stimulation. It uses mechanomyographic signals to assess nerve function in real-time, enabling safer and more effective surgical interventions involving nerve mapping and monitoring.

CORIOGRAPH Pre-Op Planning and Modeling Services is software designed to assist surgeons with preoperative planning for orthopedic surgeries such as knee, hip, and shoulder replacements. It uses patient imaging scans to create personalized surgical plans and allows surgeons to simulate and modify implant positioning before surgery, helping improve precision and surgical outcomes.

The Globe Pulsed Field System is a catheter-based system designed for cardiac anatomical and electrophysiological mapping and stimulation. It helps clinicians visualize and assess electrical activity in the heart to diagnose and treat cardiac conditions more effectively by creating detailed 3D electroanatomical maps and guiding stimulation therapy.

The HyperSnap Surgical System (HSS) is an advanced imaging system used during surgery that combines real-time RGB video with hyperspectral imaging to show tissue oxygen saturation. It uses AI and deep learning to reconstruct images and provide instant feedback to surgeons about tissue health, potentially helping identify tissue ischaemia during open or minimally invasive procedures.

The EVIS EXERA III Bronchovideoscope series from Olympus Medical Systems Corp. includes several bronchoscopic models designed to provide high-quality endoscopic imaging within the airways and tracheobronchial tree. Integrated with Olympus video system centers, these bronchoscopes allow clinicians to perform diagnosis and endoscopic surgery with advanced imaging modes including Narrow Band Imaging (NBI), Red Dichromatic Imaging (RDI), Texture and Color Enhancement Imaging (TXI), and Blue Light Imaging - Multi-wavelength Active Light (BAI-MAC). The devices offer improved image quality, high resolution, and features such as pre-freeze and automatic brightness adjustment. They are compatible with EndoTherapy accessories for biopsy and treatment. These devices facilitate better visualization and maneuverability for clinicians during bronchoscopy procedures.

The Navient Image Guided Navigation System (ENT) by ClaroNav is a surgical navigation tool designed to help ENT surgeons accurately locate anatomical structures by using preoperative CT and MR imaging combined with real-time optical tracking. It assists in planning and navigation during various ENT procedures, improving surgical precision and safety.

PathPresenter Clinical Viewer is a web-based software tool designed to help pathologists view and manage high-resolution digital images of tissue slides. It facilitates diagnosis by allowing detailed image navigation, annotation, and measurement, improving pathology workflow and accuracy.

The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.