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.

The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.

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.

Tyto Insights for Rhonchi Detection is an AI-enabled software system that helps healthcare professionals detect abnormal lung sounds known as rhonchi from lung sound recordings. The system processes audio recorded using a compatible FDA-cleared digital stethoscope and provides decision support to clinicians in evaluating lung health, aiding in diagnosis and treatment decisions.

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.

TipTraQ is a wearable fingertip device designed to assist in evaluating and diagnosing sleep apnea in adults. It collects physiological data like photoplethysmogram (PPG) and movement via accelerometer, then uses cloud-based AI algorithms to analyze the data and determine critical sleep parameters such as total sleep time, REM time, and apnea-hypopnea index. This helps clinicians diagnose sleep apnea more efficiently both at home and in clinical settings.

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn sensor device designed to continuously measure oxygen saturation (SpO2) and pulse rate in infants. It sends the measured data via Bluetooth to a mobile device running a dedicated app for display and monitoring. This helps caregivers monitor infant vital signs in hospitals, home care, and medical facilities non-invasively in real time, with visual and auditory alarms for abnormalities.

The Respiration Data Management Software is a healthcare application installed on a computer that helps clinicians monitor and manage respiratory therapy treatment data from compatible CPAP and BPAP devices. It allows viewing treatment data, generating reports, and remotely adjusting therapy device settings to assist in patient care within healthcare facilities safely and efficiently.

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.