FDA Radiology AI Devices

Spine CAMP™ (1.1) is an automated software that analyzes X-ray images of the lumbar and cervical spine to generate measurements and visualizations of spinal alignment, stability, degeneration, and motion. It supports healthcare professionals in clinical decisions related to spinal health by producing detailed reports from radiographic data.

The Voluson SWIFT and Voluson SWIFT+ are advanced diagnostic ultrasound systems used by healthcare professionals for imaging and analyzing the human body and fluids. These systems support multiple clinical applications including fetal/obstetrics, abdominal, cardiac, musculo-skeletal, and vascular imaging using various ultrasound modes such as B-mode, Doppler, 3D/4D imaging, and elastography. They feature AI-assisted tools like Auto-Caliper for improved measurement accuracy, enhancing clinicians' ability to perform exams efficiently and precisely in hospital or clinical settings.

IB Lab LAMA is a software tool that automatically analyzes full leg X-rays to measure discrepancies in limb length and assess knee alignment. It uses AI deep learning technology to provide precise geometric measurements to assist healthcare professionals in evaluating leg deformities and alignment issues, thereby supporting diagnosis and treatment planning.

Critical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.

The Saranas Early Bird Bleed Monitoring System is a single-use medical device designed to be inserted into the femoral artery or vein during endovascular procedures. It detects and monitors internal bleeding by measuring changes in bioimpedance, providing early indications of potential bleeding complications to physicians. This helps clinicians maintain patient safety by enabling early intervention during or after vascular interventions.

The Ceribell Status Epilepticus Monitor is a software medical device that analyzes EEG data captured from a headband device to automatically detect electrographic status epilepticus in patients at risk of seizures. It provides timely diagnostic support to clinicians in acute care environments, enabling faster treatment decisions for this critical neurological condition.

Genius AI Detection 2.0 with CC-MLO Correlation is an AI-powered software designed to assist radiologists by analyzing digital breast tomosynthesis images to detect and mark suspicious soft tissue densities and calcifications. It provides confidence scores for each detected lesion, helping clinicians interpret breast cancer screening exams more effectively, including correlation between different standard mammographic views for better diagnosis workflow.

The GI Genius System 100 and 200 are AI-powered computer-assisted detection tools used during colonoscopy to help doctors identify colonic lesions such as polyps and adenomas in real time. It integrates with standard white-light endoscopy video systems and highlights suspicious areas to support clinicians without replacing clinical judgment.

The Radiation Planning Assistant (RPA) is a web-based software tool designed to automate and assist in planning radiation therapy for cancers of the head and neck, cervix, breast, and brain metastases. It uses CT images to create contours and treatment plans with photon beam irradiation, improving efficiency and precision in radiotherapy treatment planning. The system generates outlines of organs and tumors and proposes radiation dose plans, which clinicians then review and adjust in their own treatment planning systems before use.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a transportable ultrasound device that provides high-resolution diagnostic imaging across various modes including B-mode, Doppler, and M-mode. It incorporates an AI-based software feature that automatically detects and quantifies lung B-lines and merged B-lines from ultrasound videos to assist clinicians in assessing lung conditions such as pneumonia and pulmonary edema. The system supports multiple transducers and is designed for use by healthcare professionals in diverse clinical settings.