Singaporean startup Respiree gets US FDA 510(k) for respiration monitor
Respiree, a med tech spinoff of Singapore’s Agency for Science, Technology and Research, has obtained the United States Food and Drug Administration’s 510(k) clearance for its wearable cardio-respiratory sensor device.
The RS001 device directly measures respiration in patients dealing with cardio-pulmonary 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 physiologic signs such as tidal volume and duty cycle.
After securing such a major clearance, Respiree will seek further approval for the device’s expanded indication for use and software. RS001 has also been cleared in both Europe and Australia after getting respective clearances.
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WHY IT MATTERS
COPD affects an estimated 200 million people worldwide. It is known to be the third deadliest disease globally, claiming 3.2 million lives each year, according to the WHO. This high disease burden is said to be driven by exacerbations or worsening conditions in patients.
“COPD exacerbations drive both morbidity and mortality. It is important to be able to identify them early and prevent them with the right therapeutic,” said Respiree CEO and founder Dr Gurpreet Singh.
Respiree’s wearable sensor device helps in this endeavour by identifying COPD exacerbations “not hours or minutes in advance, but days in advance,” Dr Singh noted.
THE LARGER TREND
The wearable sensor device is also part of a remote patient monitoring system which Respiree developed with Changi General Hospital. Late last year, they announced that they are validating AI algorithms for predicting patient deterioration as part of the said RPM system.
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