RTM Sense (A-0001)
RTM Vital Signs, LLCRTM 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.
Intended Use
RTM Vital Signs RTMsense is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in adult patients non-invasively and graphically report respiratory rate.
Technology
The RTMsense system consists of a wearable trachea sound sensor (TSS) adhered near the patient's neck that acquires acoustic signals during inhalation and exhalation, wireless transmission of data via Bluetooth to a tablet running a web-based app, and cloud-based proprietary algorithms analyzing signals to calculate respiratory rate, displayed in real time.
Performance
Performance testing including bench tests, adhesion, battery testing, wireless data transmission validation, software verification, and clinical studies comparing RTM Sense respiratory rates to capnometer measurements demonstrated the device's accuracy, reliability, and safety with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
9 months - 2
FDA Approval
6/27/2025
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