FDA Radiology AI Devices

RT Elements 4.5 is a computer-based software suite designed to assist clinicians in planning radiation treatments for brain, spine, and extracranial lesions. It supports stereotactic and conformal radiation therapy by providing optimized treatment plans, dose reviews, and AI-based tumor segmentation, helping improve accuracy and efficiency in patient treatment.

The VitalSigns 1-Lead Holter (VSH101) is a wireless, ambulatory ECG monitoring device that records, transmits, and stores single-channel ECG data via Bluetooth to a compatible mobile app. It helps healthcare professionals and individuals with cardiac conditions by providing supplementary ECG information for patient monitoring.

The FUJIFILM Endoscope Model EB-710P is a flexible bronchoscope designed to observe, diagnose, and treat the trachea and bronchus. It works with the FUJIFILM Processor EP-8000, which provides illumination, processes visual signals from the endoscope, and enables image recording. This combination aids clinicians in examining airways more effectively under physician management.

Aurora is a medical imaging system that combines nuclear medicine (SPECT) and CT imaging to help healthcare professionals detect and evaluate diseases including cardiovascular, neurological disorders, and cancer. It provides enhanced imaging through various scanning modes, real-time processing features including deep-learning based automatic kidney segmentation, and supports therapy planning and monitoring.

TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.

The PhysCade System is a specialized AI-driven software and hardware platform designed to analyze and visualize intra-cardiac electrophysiological data collected during heart rhythm studies. It helps clinicians by providing detailed maps identifying early activation sites and other features of interest in the heart during arrhythmia procedures. This assists physicians to make more informed clinical decisions during electrophysiology procedures, improving patient care for those with heart rhythm disorders.

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are surgical navigation tools that use fluoroscopic 2D and CT 3D imaging to precisely guide the placement of surgical instruments and implants during spine surgery. By registering images intraoperatively, they help surgeons perform accurate and safe spinal implant procedures, such as lumbar pedicle screw placement, improving surgical outcomes.

Radius VSM and Accessories is a wearable multi-parameter patient monitor from Masimo Corporation designed for continuous monitoring of vital signs like heart rhythm, blood pressure, oxygen saturation, respiratory rate, and skin temperature. It helps clinicians monitor patients' cardiovascular and respiratory status in hospital settings and includes arrhythmia detection, facilitating timely clinical intervention and patient management.

The Flexible Ureteroscope (U-Scope) by Opcom Medical Inc. is a sterile, single-use, flexible digital video ureteroscope designed to visualize the urinary tract (including urethra, bladder, ureter, and kidney calyces) using a miniature CMOS camera and LED illumination. It connects to a reusable camera-controlled unit which processes and displays images and videos, enabling physicians to perform diagnostic and therapeutic procedures. This system aids clinicians by providing live, high-quality imaging to guide interventions in the urinary tract.

The InsightersTM Single-use Bronchoscope System is a medical imaging device consisting of disposable flexible bronchoscopes and a compatible workstation display. It provides clear, real-time images for clinicians to observe, diagnose, and treat diseases affecting the trachea, bronchi, and lungs. The device enhances clinical workflow with its portability, image clarity, and single-use design to reduce risk of infection.