Smart sensor platform for respiratory health receives FDA clearance for home use
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Strados Labs announced it received FDA clearance for home use of its smart sensor platform for respiratory health, according to a press release.
The RESP Smart Sensor Platform provides early, remote detection of key changes in lung acoustics and ventilation patterns to enable prediction of worsening respiratory diseases, according to the company. The platform detects lung sounds associated with asthma, COPD, heart failure and infectious diseases including COVID-19, according to the release.
The FDA clearance will allow users to track objective symptoms associated with pulmonary disease from home and connect with doctors remotely to track improvement or decline.
“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,” Mitchell Glass, MD, chief medical officer at Strados Labs, said in the release. “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 platform has been used in hospitalized patients as well as those transitioning to home care after an acute exacerbation, according to the release.
“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,” Nick Delmonico, CEO and co-founder of Strados, said in the release. “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 platform can be integrated into telehealth, electronic ICUs, clinical trial management platforms and telemetry across health care settings, according to the company.