FDA Radiology AI Devices

Ultrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.

Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced diagnostic ultrasound devices that use AI-powered AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements for adult echocardiography. These systems help healthcare professionals efficiently perform and analyze cardiac ultrasound exams, improving measurement accuracy and workflow in clinical environments such as hospitals and clinics.

BoneMetrics (US) is an AI-powered software that automatically measures Cobb angles on frontal spine x-rays to assist healthcare professionals in evaluating spinal deformities such as scoliosis. It integrates with existing imaging systems to provide quantitative angle measurements that can support clinical decision-making, improving workflow efficiency and consistency.

The Navient Image Guide Navigation System is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during neurosurgical procedures. It helps surgeons plan and navigate in real time using CT or MR images, improving accuracy and safety in cranial operations such as tumor resection and biopsies.

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.

TipTraQ is a wearable fingertip device designed to assist in evaluating and diagnosing sleep apnea in adults. It collects physiological data like photoplethysmogram (PPG) and movement via accelerometer, then uses cloud-based AI algorithms to analyze the data and determine critical sleep parameters such as total sleep time, REM time, and apnea-hypopnea index. This helps clinicians diagnose sleep apnea more efficiently both at home and in clinical settings.

Contour ProtégéAI+ is a medical imaging software accessory that leverages machine-learning algorithms to automatically create contours of anatomical structures on CT and MR images. It supports clinicians by automating and assisting in image segmentation, which is critical for adaptive therapy, radiation treatment planning, and patient follow-up. The software provides significant time savings and improves contouring consistency, while allowing clinicians to review and edit results as needed.

The Sonicaid Team3 is a fetal monitoring system designed for non-invasive and invasive monitoring of fetal and maternal physiological parameters during pregnancy. It helps clinicians assess fetal well-being through ultrasound, fetal heart rate monitoring, and includes the Dawes-Redman CTG analysis software to evaluate cardiotocographs, aiding in the identification of abnormal or reassuring fetal heart patterns.

The Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical imaging device designed to provide high-resolution, real-time images of coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light delivered via a fiber-optic catheter to visualize coronary tissue, aiding clinicians in diagnosis and treatment planning.