Digital therapeutics startup Respiree™ receives FDA clearance for RS001 cardio-respiratory wearable."

09 March 2023 | Thursday | News

- Digital therapeutics startup Respiree has received the United States Food and Drug Administration's 510(k) clearance for its RS001 cardio-respiratory wearable.

Illustrative Image of Respiree™’s RS001 Cardio-respiratory Wearable

The RS001 is a chest wearable that measures respiration directly and can be used on patients suffering from cardio-pulmonary diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure.


Respiration offers the number one vital for predicting clinical deterioration. Unfortunately, respiration data is often missing within workflows though key to saving lives and preventing health decline. Please see here for more information.

Take for example COPD that is a chronic global lung disease. According to the US Centers for Disease Control and Prevention, COPD affects 15.7 million Americans with more than 150,000 Americans dying each year – that is 1 death every 4 minutes! COPD 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," said Respiree's CEO and Founder Dr Gurpreet Singh.

With its first 510(k) clearance, Respiree 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 is CE marked, approved for use in Australia by the Therapeutics Goods Administration (TGA) and has now received clearance from the United States Food and Drug Administration (FDA).

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