FDA Radiology AI Devices

The Single Use Aspiration Needle models NA-201SX-4021 and NA-201SX-4022 by Olympus Medical Systems are sterile, disposable needles used alongside ultrasound endoscopes to perform fine needle aspiration of submucosal and extramural lesions in the tracheobronchial tree. They help clinicians obtain tissue samples safely and effectively under real-time ultrasound guidance.

RTM Sense is a wearable respiratory monitoring system that continuously tracks breathing in adult patients by analyzing sounds from airflow in the trachea. It wirelessly transmits data to a tablet, where a proprietary software algorithm analyzes and displays respiratory rate, helping clinicians monitor breathing as an adjunct to other clinical information.

AeviceMD is a wearable, non-invasive electronic stethoscope that records lung sounds from pediatric patients. It stores these sound recordings securely on a cloud platform, allowing healthcare professionals to later review, compare, and analyze them to support clinical assessments. The system includes hardware sensors, docking station, mobile and web apps, and cloud analytics to facilitate longitudinal monitoring of lung sound data.

Philips VSC-MEDlib is a software library intended to automatically and contactlessly measure respiration rate by analyzing video streams of a patient's torso during virtual consults or health screenings. It uses camera-captured images to detect torso motion and calculate breathing frequency, providing clinicians with an additional vital sign measurement to support patient assessment. It is designed for use in clinical or home environments under healthcare professional supervision.

The PowerCube+ Series by GANSHORN Medizin Electronic GmbH is a medical device designed for professional healthcare settings to measure lung function in patients 5 years and older. It performs multiple pulmonary function tests such as Spirometry, Body Plethysmography, Lung Diffusion, Occlusive Resistance, and Respiratory Muscle Strength measurements. These tests help clinicians obtain detailed physiological parameters used to diagnose and monitor lung conditions. The device uses ultrasound technology for flow measurement, an air-tight chamber for body plethysmography, and gas analyzers to assess lung diffusion capacity. It supports electronic medical record integration, providing accurate and reliable data for respiratory assessment.

ScanNav Anatomy Peripheral Nerve Block is a software that assists healthcare professionals in identifying and labeling anatomical structures in real-time ultrasound images during preparation for ultrasound-guided regional anesthesia. It uses deep learning AI to highlight key nerve block anatomical regions, improving procedural accuracy and safety.