Respiree gets FDA clearance for cardio-respiratory wearable
pharmafile | March 9, 2023 | News story | Medical Communications |
Respiree, a digital therapeutics start-up, has secured the 510(k) FDA clearance for its RS001 cardio-respiratory wearable.
RS001 is a chest wearable which measures the respiration of patients with cardio-pulmonary diseases like congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD). Respiree offers targeted predictions and diagnosis of cardio-respiratory diseases by utilising a mix of advanced breath-cardio sensors and AI.
The company commented on the importance of the device, stating that respiration is the number one prediction for clinical deterioration, however respiration data is often missed or overlooked within workflows.
Respiree now intends to pursue clearances for expanded indications for the use of chest wearables and software, which will use proprietary data from the RS001 to help predict cardio-pulmonary diseases.
Respiree CEO and founder Gurpreet Singh said: “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.”