RTM Vital Signs Receives FDA Clearance for its Respiratory Monitoring System (RMS)
Philadelphia, PA — July 22, 2025 — RTM Vital Signs, LLC, a leader in advanced respiratory monitoring, proudly announces that its 1st generation Respiratory Monitoring System (RMS GEN I) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a wearable device that continuously measures a patient’s respiratory rate.
The RMS GEN I system offers a novel, non-invasive solution for continuous monitoring of respiratory function. Designed for use across hospital, ambulatory, and clinical research settings, it delivers real-time insights into breathing irregularities, supporting early intervention and improved patient outcomes.
“This FDA clearance marks a pivotal milestone in our mission to bring reliable respiratory intelligence to the point of care,” said Nance Dicciani PhD, CEO of RTM Vital Signs. “The GEN I system reflects interdisciplinary collaboration and is engineered to meet clinical needs with accuracy, simplicity, and patient comfort.”
“RTM’s proprietary technology can address a critical need in patient care – identifying pre-symptomatic respiratory compromise, which is an early indicator of many types of health problems,” said Dr Jeffrey Joseph, RTM’s Scientific and Clinical Advisory Board Chair. “Early and accurate detection of clinical deterioration and initiation of appropriate therapy will improve clinical outcomes, decrease costs, and save lives.” With GEN I now FDA-cleared, the company plans to conduct a variety of pilot studies in hospital and nursing home environments, and will begin a large NIH-funded clinical trial to demonstrate the RMS capability to accurately detect and predict opioid induced respiratory depression (OIRD) in post-operative surgical patients receiving opioids for pain management.
The RMS is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and general wards, to monitor breathing in adult (at least 22 years old) patients.
RMS is a non-invasive system that graphically displays respiratory function against time and reports respiratory rate. RMS measurements are used as an adjunct to other clinical information sources.
Research referenced in this press release is supported by the National Institutes on Drug Abuse (NIDA) under award number R44DA059491. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIDA.
Media Contact: Denise Devine, Denise Devine@RTMVitalSigns.com, 484-431-0674
