FDA Radiology AI Devices

FEops HEARTguide is a software tool that helps clinicians simulate and plan the implantation of left atrial appendage occlusion devices in individual patients. By using CT scans to create patient-specific heart models and incorporating device mechanics, it predicts how the device will deform and interact with the tissue, aiding pre-procedural decision-making to improve procedural outcomes and device placement.

The TruSPECT Radiological Image Processing Station is a nuclear medicine imaging software system designed to process and display SPECT images alongside CT/MR scans for enhanced clinical diagnosis, including attenuation correction and quantitative assessment. It supports AI-based attenuation correction to improve image quality and aids clinicians, particularly for cardiac imaging and other clinical applications, by providing advanced visualization, segmentation, and quantitative tools.

Kosmos is a handheld diagnostic ultrasound system combined with ECG and digital auscultation capabilities. It helps healthcare professionals perform clinical assessments across multiple body regions such as cardiac, thoracic, abdominal, vascular, and musculoskeletal areas by providing synchronized ultrasound images, ECG rhythms, and auscultation sounds. The device supports various ultrasound modes including B-mode, Doppler, and harmonic imaging, enhancing diagnostic capabilities in a single portable platform.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

The MAGNETOM Free.Max is a magnetic resonance imaging (MRI) system that creates detailed cross-sectional images of the internal structures and functions of the head, body, and extremities. It includes advanced hardware and software features to enhance image quality and assist clinicians in diagnosing various conditions by providing clear and accurate images.

QMENTA Care Platform Family is a software system that helps hospitals and clinicians receive, store, and analyze medical images from CT, MRI, and PET/CT scans. It integrates multiple AI-powered applications to process these images, assisting doctors in diagnosing by providing advanced image analysis and organized data accessible over a network.

The OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical are advanced OCT imaging systems designed for use in cardiovascular catheterization labs. Paired with compatible Dragonfly imaging catheters, these devices provide detailed imaging of coronary arteries and physiological measurements to help physicians assess coronary lesions and determine the need for intervention.

The HS40 Diagnostic Ultrasound System by Samsung Medison is a versatile ultrasound imaging device designed to capture and display detailed ultrasound images using various modes such as 2D, Doppler, and 3D/4D imaging. It supports a wide range of clinical uses from obstetrics and gynecology to cardiac and musculoskeletal imaging, helping healthcare professionals diagnose conditions and analyze anatomical structures safely and effectively.

SubtleMR is a software tool that enhances MRI images by reducing noise or increasing sharpness using a convolutional neural network algorithm. It works with various MRI scans of the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal areas to help radiologists obtain clearer images for better interpretation and diagnosis.

The OTIS 2.1 Optical Coherence Tomography System is a medical imaging device that provides high-resolution, two-dimensional, cross-sectional real-time images of excised human tissue microstructures. It uses non-ionizing optical radiation to create detailed subsurface images, aiding clinicians in evaluating tissue samples. The device automates image acquisition and review, allowing users to identify and annotate regions of interest efficiently, supporting clinical decision-making and improving visualization during tissue evaluation.