FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The CIONIC Neural Sleeve NS-200 is a wearable device that helps adults with foot drop and muscle weakness by electrically stimulating specific leg muscles to assist ankle and knee movements. It includes sensors to measure muscle activity, providing real-time biofeedback to guide stimulation and rehabilitation. It aims to improve gait, facilitate muscle re-education, prevent atrophy, and increase blood flow.

FDA #
K243828
Product Code
GZI

Momentum Spine is a mobile application that uses a smartphone camera to capture a 3D model of the torso and applies artificial intelligence to measure and track postural asymmetries, including scoliosis. It assists clinicians and patients in monitoring spinal health by providing quantitative assessments such as predicted Cobb angle and asymmetry metrics, enhancing early detection and management of spinal deformities.

FDA #
K232023
Product Code
LDK
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