FDA Gives Clearance to PulmoScan Device for At-home Lung Function Monitoring

The U.S. Food and Drug Administration has granted clearance to PulmoScan, a device developed by Cognita Labs that will facilitate at-home testing of lung function.

The device could be useful in providing care to people with respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). PulmoScan may allow people with COPD to test their lung function at home, with a device that is easier to use for older patients.

“Millions of patients don’t have access to objective lung testing, even in developed countries,” Gaurav Patel, co-founder and CEO of Cognita Labs, said in a press release.

“Our goal is to bring state of the art testing to all patients,” Patel said.

Lung function assessment currently is most often done through spirometry, which involves measuring the amount of air a person can forcefully exhale.

However, spirometry has some drawbacks. One is that forceful exhalation can be a challenge for young children and older individuals, making it difficult to perform spirometry in these populations. Forceful breathing, and coughing that results from such breathing, also can increase the amount of airborne respiratory droplets a person projects in the air, which can increase the risk of transmitting certain diseases, including COVID-19.

For this reason, the American Lung Association and other groups have advised limiting the use of spirometry in the present pandemic.

Instead of requiring a forceful breath, PulmoScan uses oscillometry — gentle pressure waves that can help identify airway blockages and stiffening walls in the lungs. The device assesses respiratory impedance, which consists of resistance, or how open the airways are, and reactance, or the flexibility of the airways. Oscillometry results in a simpler test that requires minimal effort on the part of the person being tested.

This easier testing method has been studied and validated over many decades, according to Cognita Labs. But until now, there has not been a portable and affordable device that can be used for at-home testing, the company said.

PulmoScan is a handheld device that delivers fast results — it takes about a minute to complete a test — and is safe for children as young as age 4, the company said.

The device can be operated wirelessly, further reducing operational risks. It also has an associated cloud-powered app platform that patients and physicians can use to manage the medical condition and intervene, if needed.

Chris Landon, MD, of the Ventura County Medical Center, in California, has been an early user of PulmoScan.

“Our nurses are always overwhelmed with patients and sometimes it is not possible to get quality results from young patients. PulmoScan allows us to do a quick test and still get a reliable measure of lung condition,” Landon said. “Nurses also feel more comfortable around patients conducting PulmoScan tests during the pandemic.”

Of note, the oscillometry method used on PulmoScan is reimbursable via CPT code 94728. The device is covered by the recently released reimbursement codes for remote patient monitoring.