Strados Labs Receives FDA 510(k) Clearance for Home Use of its Smart Sensor Platform for Respiratory Health, RESP®

by | May 3, 2022

Philadelphia, PA May 3, 2022Strados Labs, a medical technology company harnessing the power of smart sensors, machine learning and proprietary algorithms to provide early detection and predictions of worsening respiratory diseases, today announced it has received FDA Class II 510(k) clearance for home use of its first product, RESP®, which make this its second FDA clearance in less than 18 months.

The approval for home use is a major milestone for Strados, allowing the product to be used for Remote Patient Monitoring (RPM) and Telehealth. This latest clearance enables patients to track objective symptoms associated with pulmonary disease at home and connect to a doctor remotely via telehealth and RPM. RESP® technology has the ability to detect lung sounds associated with events like heart failure, COPD, asthma, and infectious diseases like COVID-19. Clinicians will also now have the ability to track signals of improvement or decline in patients that might be experiencing these events.

Strados Labs Chief Medical Officer Dr. Mitchell Glass said, “This 510(k) clearance expands the use of RESP® to include home care of more than 5 million patients who are discharged from the hospital or ED each year with a primary diagnosis of asthma, COPD or Heart Failure. More than 30 million patient visits each year can be improved, or avoided entirely, by adding real time remote auscultation to the tools of the caregiver who has ready access to the patient’s RESP® archive for comparison.”

The RESP® platform has been used in both hospitalized patients as well as patients transitioning to home care after acute exacerbation. The company will be presenting their investigational findings at the American Thoracic Society conference on May 13-18 with respect to the platform’s ability to detect early events related to cardiopulmonary disease, as well as their algorithms to automatically detect cough, wheeze, crackles and other adventitious sounds validated by pulmonary specialists.

Strados is currently working with research organizations and pharmaceutical companies to capture lung sound measurements and is looking forward to expanding the Company’s reach into the patient home. Strados’s vision for the use of RESP® in home settings is to create an opportunity to learn more about patients in real world settings to help clinicians better understand how respiratory events are triggered and how therapeutic intervention impacts patient symptoms like coughing or wheezing objectively. Remotely monitoring patients outside of a clinical setting to glean critical real-world insights, for the first time, is now possible with RESP®.

“We are excited to reach this critical milestone that will allow clinicians to gain a clearer understanding of a patient’s respiratory health at home and see the entire patient journey,” said Strados’ co-founder and CEO Nick Delmonico. “As an asthma patient, I know how critical early detection of symptoms can be in helping to avoid hospitalization. RESP® enables clinicians to gain insights into wheezing and coughing beyond the clinic or hospital, and we believe this will be a game changer.”

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 second FDA clearance.

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About Strados Labs

Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados was recently granted a CE Mark for RESP® and received its FDA Class II 510(k) clearance for it last December. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, etc.) as it moves into 2022—with plans to add heart failure and pediatrics in late 2022. The Company is based in Philadelphia and is a privately held company. For more information, visit:

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Lauren Lorow 

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