The United States Food and Drug Administration (FDA) has granted clearance to the Singapore-based startup Respiree’s RS001, a chest wearable that measures respiration. The device offers early detection of heart and lung deterioration through the direct capture of respiratory rate and tidal volume, which is how much air goes in and out of the lungs with inhales and exhales. The wearable also measures 13 other biometrics, including oxygen saturation (SpO2), heart rate and variability, venous oxygen saturation (SvO2), and skin and body temperature.

Identifying chronic obstructive pulmonary disease (COPD) may be the device’s widest application. According to the U.S. Centers for Disease Control and Prevention (CDC), COPD affects over 15 million people in the United States and was the sixth leading cause of death in the country in 2020. With a death rate of about 1 person every 4 minutes, over 150,000 Americans die of COPD each year. If you have COPD, the CDC recommends getting vaccinated during flu season to reduce the risk of flare-ups. Made more possible through early detection via a wearable such as the RS001.

Respiree CEO Dr. Gurpreet Singh says, “COPD exacerbations drive both morbidity and mortality. It is important to be able to identify them early and prevent them with the right therapeutic. By using Respiree’s RS001, physicians can now have the opportunity to identify exacerbations not hours or minutes in advance, but days in advance. This can enable patients to quickly receive preventive care before exacerbation onset.” 

The RS001 is part of Respiree’s iRIS Connected Care, a cardio-pulmonary platform that includes iRIS Home, a remote patient monitoring (RPM) service. The platform’s iRIS Centre feature monitors for indications of emergency situations, with customizable alerts and a risk management system on a dashboard. iRIS Centre also integrates the user’s vital signs into their electronic health records (EHRs). While the platform’s iRIS Spot is a standalone system in which an anesthesia and sedation specialist monitors breathing patterns and respiratory rate in real time.

Through a connected app, Respiree users can view trends and vital readings, access connected records and patient-reported outcomes, schedule and conduct telehealth consultations, and organize appointments and medications on a calendar. Respiree says it plans to solicit more FDA clearances in the future, with a further focus on using respiratory digital biomarkers to identify and predict worsening of congenital heart failure and conditions including COPD.