Strados RESP Wireless Bio-Sensor for Non Invasive Lung Sound Monitoring, Now FDA Cleared

Strados Labs, a health technology developer of remote respiratory devices and software, today announced it has received FDA clearance for its first product, RESP, a system for measuring, recording and analyzing lung sounds remotely across healthcare settings. RESP attaches to the chest and much like a stethoscope listens for typical auscultation sounds, as well as coughs and wheezes.

Patients with respiratory diseases are often rushed to the emergency room with acute decompensation. If not managed properly, chronic respiratory disease prolongs the episode of care or leads to hospital readmissions that are costly and burdensome to the patient.

The current standard of care, in an inpatient setting, relies on labor-intensive, clinical assessments to detect signs of worsening disease progression. In the outpatient setting, disease monitoring relies solely on self-reporting by patients.

Occasionally, patients have the aid of an instrument, such as a peak flow meter, but these aids are prone to user error and cannot always accurately report critical data.

Additionally, patients with COPD (Chronic Obstructive Pulmonary Disease) and asthma often receive inadequate treatment due to poor communication between the patient and clinician, poor disease status assessment by the clinician, inconsistent use of medication, or the unreliability of peak flow measurements.

A system capable of continuously and remotely monitoring a patient’s respiratory health could address this disconnect in patient care. Utilizing an intelligent patient monitoring system could improve patient care triage, reduce the length of hospital stay, lower the healthcare costs incurred by expensive pulmonary complications, and standardize the objective assessment of a patient’s respiratory health.

RESP System: Wireless Non Invasive Bio-Sensor

The RESP system can capture, store, and make available for clinical analysis these key changes in a patient’s lung sounds remotely with a small body-worn sensor and a cloud-based, HIPAA compliant software system. The system can cancel out a great deal of the noise and track trends in lung sounds.

The RESP system has been used in clinical trials to help researchers quantify changes in lung sounds over time to compare against treatments, patient-reported outcomes, and other vital signs

Dr. Mitchell Glass, the Chief Medical Officer of Strados Labs, said, “This wearable technology will allow us to follow our patients in healthcare settings more effectively, by providing regular interval listening between clinician visits, by archiving the patient’s lung sounds for future comparisons and by reducing the variability in auscultatory documentation that presents a major problem both in patient care and in clinical trials.”

The company is currently working with research organizations and pharmaceutical companies to capture lung sound measurements as primary and exploratory endpoints to support their trials. Strados Labs sees the use of RESP in trials as a way to learn more about patient-reporting outcomes (ePRO) to help sponsors better understand how treatments and therapies impact patient symptoms like coughing or wheezing objectively.

This system for remote lung measurement aligns with the sponsor goals of minimizing patient burden, maintaining patient privacy, and decentralizing trial data collection to optimize recruitment and retention.

“We are excited to finally bring the RESP technology to clinicians, scientists and patients who need it most,” said CEO Nick Delmonico. “The FDA clearance is a major milestone for our early stage company.

Our team worked tirelessly and overcame obstacles, many that were out of our control due to COVID19, to achieve this goal during a particularly challenging year for small businesses. We are thrilled to be one step closer to our mission of making every breath count.”

The RESP technology can be integrated into various health data systems, including telehealth, eICUs, clinical trial management platforms, and telemetry across healthcare settings. This is the company’s first FDA clearance.

About Strados Labs

Strados Labs is a health technology company that is focused on enhancing our understanding of pulmonary diseases and respiratory health to fight disease progression and provide better patient care.