PR Newswire
09 Mar 2023, 05:44 GMT+10
![]() |
SINGAPORE, March 9, 2023 /PRNewswire/ -- Digital therapeutics startup Respiree has received the United States Food and Drug Administration's 510(k) clearance for its 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.
WHY IT MATTERS
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).
About Respiree
Respiree (www.respiree.com) is a digital therapeutics company providing personalized healthcare services for cardio-pulmonary disease management using a combination of proprietary breath-cardio sensors, AI and workflow integrated UIUX.
Respiree is deployed internationally. Respiree is CE marked, approved for use in Australia by the Therapeutics Goods Administration and has now received clearance from the United States Food and Drug Administration.
Get a daily dose of Philippine Times news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Philippine Times.
More InformationWASHINGTON DC, - U.S. President Donald Trump has claimed a ceasefire has been reached between Israel and Iran. He made the claim on...
DUBAI, U.A.E.: British Iranians living in the U.K. are taken aback when they try to reach their families in Tehran on the phone and...
BRASILIA, Brazil: Former Brazilian President Jair Bolsonaro is accused of playing a key role in an illegal surveillance operation orchestrated...
ANKARA, Turkey: A Turkish far-right politician went on trial Wednesday, facing charges of inciting public hatred—an episode critics...
LONDON, U.K.: In a landmark moment for Britain, lawmakers in the House of Commons have voted in favour of legalising assisted dying,...
Western support for Israel's right to strike Iran backs up a pattern of pre-emptive violence that critics say is further eroding international...
BARCELONA, Spain: Residents of Barcelona have devised a novel way to protest the presence of tourists in their city. Using a cheap...
CHICAGO, Illinois: For the first time in history, U.S. officials are considering a coordinated plan to vaccinate poultry against bird...
NEW YORK, New York - U.S. stocks made strong gains on Monday, brushing off concerns Donald Trump's surprise ambush of Iranian nuclear...
NEW YORK CITY, New York: The U.S. bombing of Iranian nuclear sites has cast a shadow over global markets, with investors bracing for...
SANTAREM, Brazil: As Brazil cements its position as the world's top soy exporter, a new wave of deforestation is spreading across the...
ZURICH, Switzerland: A wave of central banks across Europe surprised markets last week by lowering interest rates, responding to easing...