Respiree, a medical technology spin-off from Singapore’s Science, Technology and Research Agency, has obtained 510(k) clearance from the US Food and Drug Administration for its cardio sensor device – portable respirator.
The RS001 device directly measures respiration in patients with cardiopulmonary diseases such as COPD and congestive heart failure.
It is part of Respiree’s iRIS connected care platform, where it is used to remotely measure vital parameters including respiratory rate, heart rate, SpO2, temperature and physiological signs such as tidal volume and duty cycle.
After obtaining such a large authorization, Respiree will apply for a new approval for the extended indication of the device for use and software. RS001 has also been licensed in Europe and Australia after obtaining the respective clearances.
WHY IS IT IMPORTANT
COPD affects approximately 200 million people worldwide. It is known to be the third deadliest disease in the world, claiming 3.2 million lives every year, according to the WHO. This high disease burden is said to be due to exacerbations or worsening of patients’ condition.
“COPD exacerbations lead to both morbidity and mortality. It’s important to be able to identify them early and prevent them with the right treatment,” said Respiree CEO and Founder Dr. Gurpreet Singh.
Respiree’s wearable sensor device helps in this endeavor by identifying COPD exacerbations “not hours or minutes in advance, but days in advance,” Dr. Singh noted.
THE GREAT TREND
The wearable sensor device is also part of a remote patient monitoring system that Respiree has developed with Changi General Hospital. Late last year, they announced they were validating AI algorithms to predict patient deterioration under said RPM system.
