Digital therapeutics startup Respiree has received US Food and Drug Administration (FDA) 510(k) clearance for its RS001 cardiorespiratory wearable.
The RS001 is a chest wearable that measures respiration directly and can be used on patients suffering from cardiopulmonary diseases such as COPD and congestive heart failure.
Respiration offers the number-one vital for predicting clinical deterioration, but respiration data is often missing within workflows, according to a press release by Respiree.
COPD affects approximately 15.7 million Americans, according to data from the Centers for Disease Control and Prevention, and has one of the highest hospital readmission rates, leading to costs to providers and payors. Exacerbations or worsening conditions generally drive this high disease burden, and identifying them early can prevent further lung function decline and reduce mortality.
“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,” says Respiree CEO and founder Gurpreet Singh, PhD, in a press release.
With its first FDA 510(k) clearance, Respiree says it plans to further solicit clearances for its expanded indications for use and software that will utilize proprietary respiratory digital biomarkers from the RS001 to predict worsening conditions in diseases such as COPD and congestive heart failure.
RS001 also is CE marked and approved for use in Australia by the Therapeutics Goods Administration.
Photo caption: Illustrative image of Respiree’s RS001 cardio-respiratory wearable
Photo credit: Respiree