FDA Radiology AI Devices

The LumiRex Bronchoscope is a single-use flexible endoscope designed to provide real-time video imaging of the airways and tracheobronchial tree. It aids clinicians during endoscopic procedures by allowing visualization through a thin tube equipped with a camera and light source. The device can operate in wired or wireless modes, enabling easier maneuverability, and is designed for use in hospitals.

The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.

The Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.

MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.

The OcuMet Beacon is a scanning LED-based ophthalmoscope that captures detailed black and white infrared and autofluorescence images of the human retina. It helps eye care clinicians by providing high-quality retinal images to assist in diagnosis and management of eye conditions, supporting clinical decisions as an adjunctive imaging modality.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.

RayCare (2024A SP1) is a software system designed to support cancer treatment by assisting clinicians with treatment planning, management, scheduling, and follow-up for radiation therapy and oncology care. It includes an image viewer for reviewing and annotating images related to patient positioning during treatment, aiding clinicians in delivering precise radiotherapy treatment.

The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.

VitalRhythm is a cloud-based AI software that continuously analyzes ECG signals to detect various cardiac arrhythmias. It works with a wearable biosensor (VitalPatch) and displays results to healthcare professionals for non-urgent clinical decision-making in outpatient and non-critical care settings. It helps clinicians monitor heart rhythms remotely and efficiently, assisting in diagnosis without replacing clinical judgment.

The CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.