FDA Radiology AI Devices

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

Bunkerhill Abdominal Aortic Quantification (AAQ) is AI software designed to analyze radiological images to quantify the abdominal aorta. This helps clinicians assess and monitor conditions related to the abdominal aorta more efficiently and accurately.

PIUR tUS inside is a medical device that enhances standard 2D ultrasound devices by generating three-dimensional (3D) tomographic ultrasound volumes of the thyroid. It assists physicians in diagnosing thyroid nodules by providing volumetric information, segmentation, and quantification of sonographic characteristics. This device operates directly on compatible ultrasound scanners, integrating sensor data to create 3D images that support clinical decision-making as an add-on to regular ultrasound imaging.

RTM Sense is a wearable respiratory monitoring system that continuously tracks breathing in adult patients by analyzing sounds from airflow in the trachea. It wirelessly transmits data to a tablet, where a proprietary software algorithm analyzes and displays respiratory rate, helping clinicians monitor breathing as an adjunct to other clinical information.

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.

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 FloPatch FP120 is a non-invasive cardiovascular blood flowmeter intended for use by medical professionals in hospitals and clinical settings. It utilizes continuous wave Doppler ultrasound to assess blood flow in peripheral vasculature. The device wirelessly transmits Doppler signals to a mobile application that displays blood flow measurements such as Max Velocity, Velocity Time Integral (VTI), and Corrected Flow Time, helping clinicians noninvasively monitor vascular health.

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.