FDA Radiology AI Devices

Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.

The Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.

The Respiration Data Management Software is a healthcare application installed on a computer that helps clinicians monitor and manage respiratory therapy treatment data from compatible CPAP and BPAP devices. It allows viewing treatment data, generating reports, and remotely adjusting therapy device settings to assist in patient care within healthcare facilities safely and efficiently.

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

SpectoMed (v1.0) is a software tool for medical professionals that enables real-time 3D visualization and analysis of CT and MRI images. It supports virtual and augmented reality interfaces to aid clinicians in preoperative planning and during surgery by providing realistic spatial views of patient anatomy along with measurement tools, enhancing diagnostic assessment and surgical preparation.

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

The SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option is a computed tomography (CT) X-ray system developed by Arineta Ltd. It produces detailed cross-sectional images of the body, especially of the cardiovascular and thoracic areas, enabling clinicians to screen and diagnose lung cancer using low-dose CT protocols. This device helps physicians detect lung nodules and other thoracic abnormalities with reduced radiation exposure, supporting effective lung cancer screening programs following clinical guidelines.

The ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient outcomes.

ScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.

PeriCALM Patterns 3.0 is an AI-based software tool designed to assist clinicians in monitoring fetal well-being during pregnancy and labor. It analyzes fetal heart rate and uterine contraction signals, automatically identifying patterns such as accelerations, decelerations, baseline heart rate, and contractions. This information supports clinical decision-making for pregnant patients at or beyond 32 weeks of gestation by providing annotated summaries of the fetal monitor recordings.