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 Singapore Star 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 Singapore Star.
More InformationMADRID, Spain: Liverpool footballer Diogo Jota and his younger brother, André Silva, have died in a car accident in Spain. Spanish...
LONDON, U.K.: An unrelenting heatwave sweeping across Europe has pushed early summer temperatures to historic highs, triggering deadly...
President Donald Trump's plans to build a space-based Golden Dome missile defense shield have drawn immediate criticism from China,...
NEW YORK CITY, New York: Paramount has agreed to pay US$16 million to settle a lawsuit brought by U.S. President Donald Trump over...
LONDON, U.K.: British Prime Minister Keir Starmer won a vote in Parliament this week to move ahead with changes to the country's welfare...
WASHINGTON, D.C.: President Donald Trump will meet Israeli Prime Minister Benjamin Netanyahu at the White House on Monday. President...
FRANKLIN, Tennessee: Hundreds of thousands of Nissan and Infiniti vehicles are being recalled across the United States due to a potential...
REDMOND, Washington: Microsoft is the latest tech giant to announce significant job cuts, as the financial strain of building next-generation...
LONDON UK - U.S. stock markets were closed on Friday for Independence Day. Global Forex Markets Wrap Up Friday with Greeback Comeback...
SANTA CLARA, California: Nvidia came within a whisker of making financial history on July 3, briefly surpassing Apple's all-time market...
SACRAMENTO, California: California's multibillion-dollar farms are facing a growing crisis—not from drought or pests, but from a sudden...
WASHINGTON, D.C.: President Donald Trump says the United States could soon reach a trade deal with India. He believes this deal would...