Singapore-based startup Respiree receives US FDA 510(k) approval for a respiratory monitor

Respiree, a subsidiary of the Singapore Medical Technology Science, Technology and Research Agency, has received US Food and Drug Administration 510(k) clearance for its wearable cardiorespiratory sensor device.

The RS001 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 respiration rate, heart rate, SpO2, temperature, and physiological signs such as tidal volume and duty cycle.

Upon receipt of this major approval, Respiree will seek further approval for the extended device and software indications. The RS001 has also been approved in both Europe and Australia after receiving the appropriate approvals.

WHY IS IT IMPORTANT

COPD affects about 200 million people worldwide. According to the WHO, it is the third most lethal disease in the world, claiming 3.2 million lives annually. This high disease burden is said to be due to exacerbations or deterioration in patients.

“COPD exacerbations result in both morbidity and mortality. It is important to be able to detect them early and prevent them with the right treatment,” said Respiree CEO and Founder Dr. Gurpreet Singh.

The Respiree wearable sensor aids this quest by detecting COPD flare-ups “not hours or minutes in advance, but days ahead,” said Dr. Singh.

BIG TREND

The wearable touch 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 testing AI algorithms to predict patient deterioration under said RPM system.