According to the digital therapeutics start-up, RS001 is a chest wearable that directly measures respiration, which has to be used on patients having cardio-pulmonary diseases like congestive heart failure and COPD
Respiree has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for its RS001 cardio-respiratory wearable.
According to the digital therapeutics start-up, RS001 is a chest wearable that directly measures respiration. The device is meant to be used on patients having cardio-pulmonary diseases like congestive heart failure and chronic obstructive pulmonary disease (COPD).
Respiree said that respiration provides the number one vital for the prediction of clinical deterioration. However, respiration data is missing frequently within workflows although it is crucial to saving lives and preventing the decline of health, said the company.
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.”
RS001 marks the first 510(k) clearance for Respiree.
The company intends to further pursue clearances for expanded indications for use of the chest wearable and software that will use proprietary respiratory digital biomarkers from the RS001 for predicting deteriorating conditions in diseases like congestive heart failure and COPD.
RS001 is CE marked apart from having approval from the Therapeutics Goods Administration (TGA) for use in Australia.
Respiree aims to enhance patient outcomes and medicine at large by offering targeted predictions and diagnosis of cardio-respiratory diseases through a mix of advanced breath-cardio sensors and artificial intelligence (AI).
The digital therapeutics start-up is backed by Greenwillow Capital Management and Seeds Capital. It was founded through a spinoff from Singapore’s Agency for Science, Technology and Research (A*STAR).