FDA clears Cognita Labs’ home-use lung assessment device

29 October 2020 (Last Updated October 29th, 2020 10:55)

The Food and Drug Administration (FDA) has cleared Cognita Labs’ PulmoScan, a home-use lung assessment device that measures airway resistance and elastance.

FDA clears Cognita Labs’ home-use lung assessment device
The handheld PulmoScan enables patients to perform lung tests wirelessly at a distance with an intuitive touch screen interface for clinicians. Credit: Magic mine / Shutterstock.

The Food and Drug Administration (FDA) has cleared Cognita Labs’ PulmoScan, a home-use lung assessment device that measures airway resistance and elastance.

The device offers an alternative to existing lung tests. It sends gentle pressure waves to spot airway blockage and stiffening walls in the lungs.

The oscillometry method, the underlying technique in the system, has been studied and validated over many decades, the company noted.

Cognita Labs CEO and co-founder Gaurav Patel said: “Millions of patients don’t have access to objective lung testing, even in developed countries. Our goal is to bring state of the art testing to all patients.

“Backed by the National Science Foundation and National Institute of Health grants, our team of leading researchers has spent years on R&D to bring PulmoScan to patients.”

Nearly 10% of the population suffer from respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).

Generally, the lung test involves a forceful spirometry test, which is difficult to perform on young children and elderly patients.

The American Lung Association (ALA) and other groups have advised the use of spirometry only in critical patients because of the fear of aerosolisation, which occurs due to patient’s forced breathing and resulting coughing.

PulmoScan can be operated wirelessly from a distance, eliminating significant patient interaction for training and reducing operational risks.