Philadelphia, PA May 3, 2022 — Strados 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.”