PR Newswire
09 Mar 2023, 10:14 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 InformationIn Warsaw last February, President Joe Biden condemned the lawless Russian invasion of Ukraine: "The idea that over 100,000 forces ...
TOKYO, Japan: Fears over intensifying Chinese military activity directed towards Taiwan could escalate into war have prompted Japan, the United ...
TEGUCIGALPA, Honduras: After Honduran President Xiomara Castro severed ties with Taiwan in favor of China to gain more investment and ...
NEW YORK, New York - A Manhattan grand jury has indicted Former U.S. President Donald Trump for his role in ...
MEMPHIS, Tennessee: Tennessee authorities are slowly releasing information about a weekend car crash on a freeway that killed six young ...
JAKARTA, Indonesia: Officials from Indonesia's Aceh province said that more than 180 Rohingya Muslims landed this week by boat, in ...
NEW YORK, New York - U.S. stocks finished the third quarter with a bang on Friday. Despite a volatile start, ...
CUPERTINO, California: In a move aimed at disrupting the fintech sector dominated by Affirm Holdings and Sweden's Klarna, this week ...
BURBANK, California: Walt Disney has begun its planned lay off of 7,000 staff, which was announced earlier this year.A letter ...
NEW YORK CITY, New York: A study published this week reported that China spent $240 billion between 2008 and 2021 ...
NEW YORK, New York - U.S. stocks posted a decent rally on Thursday with all the major indices making good ...
FREMONT, California: Neuralink, Elon Musk's brain implant company, has approached the Barrow Neurological Institute, one of the largest US neurosurgery ...