FDA Radiology AI Devices

Contour+ (MVision AI Segmentation) is a software tool that uses machine learning algorithms to automatically create contour outlines of anatomical regions on CT and MRI scans. It assists clinicians in radiation therapy planning by providing initial segmentations of organs and tissues, which professionals can review and modify before treatment planning. This speeds up the workflow and improves efficiency in radiation treatment preparation.

The Materialise Shoulder System is a patient-specific medical device designed to assist surgeons in preoperative planning and intraoperative positioning of shoulder replacement components. It includes the SurgiCase Shoulder Planner software, which utilizes CT imaging to generate detailed 3D pre-surgical plans. Based on these plans, patient-specific guides and models are created to help precisely position implants during surgery, improving surgical accuracy and outcomes for total and reverse shoulder arthroplasty.

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.

The dS Knee Coil 8ch 1.5T is an 8-channel phased array MRI coil designed for use with Philips 1.5T MRI systems to produce high-resolution diagnostic images of the knee. The coil's design improves signal-to-noise ratio and patient comfort, enabling accurate imaging of knee anatomy for clinical evaluation by trained physicians.

The dS Wrist Coil 8ch 1.5T is a specialized MRI coil designed to produce high-quality diagnostic images of the wrist. It improves image clarity by using an 8-channel phased-array design for better signal reception, helping physicians accurately evaluate wrist conditions through MRI scans.

The ROSA Knee System is a robotic-assisted surgical device used during total knee replacement surgeries. It helps surgeons precisely place knee implants by using software to define spatial boundaries relative to anatomical landmarks and utilizing a robotic arm to guide bone resections and implant positioning. This system can integrate pre-operative imaging such as X-rays or MRI to plan surgeries more accurately and improve surgical outcomes.

The Spectral CT 7500 RT is an advanced computed tomography (CT) system that uses dual-layer detector technology to acquire high and low energy X-ray data simultaneously. This allows it to generate detailed cross-sectional images and analyze the chemical composition of tissues and contrast agents. It supports applications in radiology, cardiology, oncology, and radiation therapy planning, helping clinicians visualize and assess anatomical and pathological structures more accurately.

Ascent Cardiorespiratory Diagnostic Software is a standalone application used with hardware to measure, collect, and analyze lung and cardiopulmonary function tests. It helps clinicians, such as pulmonologists and cardiologists, diagnose lung and heart-related conditions by processing test data from devices like spirometers and body plethysmographs. The software provides detailed pulmonary and cardiopulmonary metrics, manages diagnostic data, and facilitates interpretation and reporting, improving diagnostic workflow.

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

The REMI-AI Rapid Detection Module (REMI-AI RDM) is an AI-based seizure detection software integrated into the REMI Remote EEG Monitoring System. It analyzes EEG data in near real-time to notify clinicians of potential electrographic seizures, aiding in patient evaluation by marking events in the EEG record. It is intended for use in non-ICU healthcare settings with adult and pediatric patients (6+ years).