FDA Radiology AI Devices

The BladderScan Prime PLUS System is a non-invasive ultrasound device that measures the volume of urine in the bladder using patented neural network technology. It assists clinicians by providing real-time bladder volume measurements and directional aiming feedback to improve patient management and care.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system designed for diagnostic imaging and fluid flow analysis across a broad range of clinical applications including ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and more. It wirelessly connects to iOS or Android devices, enabling clinicians to acquire high-resolution real-time ultrasound images and Doppler flow data for enhanced diagnostic evaluation and procedural guidance.

NeuroQuant is an AI-powered software tool that automatically processes MRI brain scans to identify and measure various brain structures and lesions. It generates detailed visual and quantitative reports, helping clinicians by automating the manual work of brain segmentation and volume measurement, thus supporting diagnosis and monitoring of neurological conditions.

The SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in a variety of clinical settings, including wound healing, plastic surgery, and vascular surgery, by providing detailed images of microcirculation in healthy or injured skin.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.

The CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.

The UNiD Spine Analyzer is a web-based software designed to help healthcare professionals view and measure spine-related images, and plan orthopedic surgeries. It assists with measurements, surgical planning including osteotomies, and templating implants, enabling surgeons to prepare and validate plans for patient-specific spine implants.

The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.