The pilot study explores the RESP® Biosensor’s potential to allow for low-effort home monitoring in patients with acute and chronic cystic fibrosis.
Philadelphia, PA, August 28th, 2025 — Strados Labs, a digital health company advancing respiratory health through wearable technologies, today announced a research collaboration with RWJBarnabas Health to evaluate its FDA 510(k) cleared RESP® Biosensor in adult patients with cystic fibrosis (CF). The pilot study, which is open to enrollment, is being conducted by Rutgers Robert Wood Johnson Medical School (RWJMS).
Led by Dr. Sabiha Hussain, professor of medicine and the program director of the Pulmonary/Critical Care Medicine Fellowship at RWJMS, the study will enroll up to 100 participants and is expected to conclude in May 2027. The primary objective is to assess whether lung sounds captured by the RESP® Biosensor correlate with disease burden and can serve as early indicators of changes in health status over a six-month period.
This prospective, observational study is among the first to explore the effectiveness of wearable respiratory monitoring at home for patients with cystic fibrosis—a population where pulmonary exacerbations are a major contributor to lung function decline, reduced quality of life, and hospitalizations. The study will evaluate the correlation between lung sounds and standard measures of disease burden, including FEV1 and patient-reported outcomes.
“We are excited to collaborate with Strados Labs to investigate a low-effort, wearable solution for monitoring respiratory health in patients with cystic fibrosis,” said Dr. Hussain, principal investigator of the study. “Home monitoring has already shown promise in improving self-management and detecting exacerbations. We anticipate that this technology will offer a simpler and more continuous way to keep patients and providers informed in real-time. And we hope it will be one step forward in allowing for individuals who do not have access to care to connect remotely, helping to further battle the barriers that exist to health equity.”
The RESP Biosensor is a non-invasive, wearable device designed to continuously and passively collect lung sounds including cough, wheeze, and crackles, breathing patterns, respiratory rate, heart rate and additional insights (FDA 510(k) clearance includes lung sounds only). Data are wirelessly transmitted via a mobile app to a secure web platform for review and analysis by healthcare teams and/or machine learning algorithms. Previous studies with the RESP Biosensor have demonstrated feasibility in disease areas such as asthma, COPD, IPF, and heart failure.
“Cystic fibrosis remains a disease where early detection of changes in respiratory health is critical” said Nick Delmonico, CEO & Cofounder of Strados Labs. “We’re excited to collaborate with the RWJMS team to bring the RESP® Biosensor to this patient population for the first time and explore how continuous monitoring may offer a new approach to manage disease burden in CF.”
The findings of this pilot study will support broader implementation of passive wearable monitoring in cystic fibrosis care and clinical research.
About Strados Labs
Strados Labs is a digital health company focused on improving the lives of patients with respiratory diseases with innovative technology. Enabling real-world monitoring of lung health, Strados Labs’ RESP Biosensor allows clinicians to continuously measure patients’ lung sounds including cough and wheeze that can indicate an exacerbation or reduced quality of life. The technology is also used to assist drug developers in assessing treatment response in clinical trials. The RESP Biosensor has two FDA 510(k) clearances, a CE mark, and is backed by multiple awards and clinical publications. Strados Labs is privately owned and based in Philadelphia, PA.
For more information, visit Stradoslabs.com or follow us on LinkedIn and X.
About Rutgers Robert Wood Johnson Medical School and RWJBarnabas Health:
Rutgers Robert Wood Johnson Medical School is one of the nation’s leading comprehensive medical schools, dedicated to the pursuit of excellence in education, research, health care delivery, and the promotion of community health. Part of Rutgers, The State University of New Jersey, Robert Wood Johnson Medical School encompasses 20 basic science and clinical departments, and hosts centers and institutes including The Cardiovascular Institute, the Child Health Institute of New Jersey, the Institute for Neurological Therapeutics, and the Women’s Health Institute.
The medical school has been recognized by U.S. News & World Report as among the top 100 medical schools in the nation and No. 1 in the state for research and primary care. Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital, an RWJBarnabas Health facility and the medical school’s principal affiliate, comprise one of the nation’s premier academic medical centers. Clinical services are provided by more than 500 faculty physicians in 200+ specialties and subspecialties as part of Rutgers Health and the RWJBarnabas Health Medical Group.
RWJBarnabas Health is New Jersey’s largest integrated health care delivery system, providing treatment and services to more than three million patients each year. Throughout RWJBarnabas Health, our dedicated physicians, nurses, and health professionals are committed to providing the highest quality of patient care and health education to the community and region.
We aim to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey—whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education.