FDA Radiology AI Devices

The UNiD Spine Analyzer is a software tool that helps healthcare professionals view, measure, and analyze medical images related to the spine. It assists in planning orthopedic surgeries by allowing surgeons to perform measurements and plan the placement of surgical implants. This tool enhances surgical planning accuracy and efficiency for spine treatments.

Arterys Oncology DL is a medical imaging software that helps clinicians view, compare, and analyze CT and MR images to detect and track lesions in cancer patients. It offers tools for 2D and 3D visualization, semi-automatic segmentation of lung nodules and liver lesions, and longitudinal tracking to support diagnosis and treatment follow-up.

The Illumeo System by Philips Medical Systems Technologies Ltd. is a software platform designed for trained professionals such as radiologists. It manages, processes, and displays medical images and associated patient data from various imaging modalities, supporting visualization, measurements, and tracking changes over time. It enhances workflow through integration with clinical systems and provides advanced viewing tools including 2D/3D views and enterprise web viewers, helping clinicians efficiently interpret imaging studies.

cNeuro cMRI is a software tool designed to automatically identify, label, quantify, and visualize brain structures from MRI scans. It helps medical professionals by automating manual processes in brain image analysis, improving efficiency in the assessment of brain volumes and abnormalities compared to a healthy reference population.

Radiomics App v1.0 by Microsoft is a software tool designed to help trained radiation oncologists, dosimetrists, and physicists create precise three-dimensional contours of tumors and healthy anatomical structures in CT and MRI scans. This assists in radiation treatment planning by providing optimized organ and tumor segmentation, supporting improved treatment evaluation and planning workflows.

The Rooti Rx System is a wearable single-lead ECG recording device that allows patients to record ECG data at home or work. The data is stored on the device and later transmitted via Wi-Fi to medical professionals’ iOS devices for post-analysis, aiding clinicians in patient cardiac monitoring and diagnosis.

Infinitt PACS 7.0 is a software system designed to store, process, and display medical images across multiple imaging sources. It allows clinicians to view and manipulate images for diagnosis using advanced tools like 3D visualization, hanging protocols, and secure network features, enhancing access to diagnostic information from anywhere via a web interface.

Quantra is a software tool designed to analyze digital mammographic images and estimate breast tissue composition. It categorizes breast density in a way that aligns with BI-RADS breast composition reporting standards to help radiologists assess breast tissue, aiding consistent reporting for breast cancer screening and diagnosis support, though it is not a diagnostic aid itself.

The Peerbridge Cor System is a wearable ECG monitoring device designed for continuous recording and transmission of heart electrical activity over 24 hours to 7 days. It helps clinicians monitor patients with symptoms like palpitations or dizziness by generating ECG reports based on FDA-cleared algorithms, aiding clinical diagnosis.

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.