Tidal Medical Technologies has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its InSee incentive spirometer accessory.
The EUA status enables to use the InSee incentive spirometer accessory for quantitatively tracking patient usage of Vyaire Medical’s AirLife incentive spirometer to treat respiratory conditions in patients with Covid-19 in hospital settings.
Incentive spirometers are designed to strengthen the muscles used for breathing and increase ventilation during recovery from respiratory illness.
In combination with an incentive spirometer, the InSee device is expected to help in treating respiratory conditions, as well as enhancing clinical outcomes by monitoring consistent usage of the spirometer.
Tidal Medical Technologies CEO Alex Farahmand said: “As we are gearing up for our initial fundraising, we are thrilled that the FDA has recognized the need for quantitative tracking of Respiratory care in a hospital setting.
“Incentive Spirometry has been used widely to help prevent pneumonia in bed-bound patients and help improve lung capacity in Respiratory patients, like Covid-19.
“With the InSee, hospitals will have objective data and smart-monitoring to better help the prevention and treatment of respiratory conditions.”
The patented InSee device holds the potential to provide 97% accuracy of spirometer measurements.
It is also compatible with 50% of existing incentive spirometers in acute care hospitals, said the company.
In addition, the company is preparing to apply an application to the FDA to secure 510(k) clearance for the wider use of the InSee device.
Tidal Medical Technologies Chief Medical Officer Hasan Kakli said: “It always baffles me that we ask patients to use Incentive Spirometers but have no way of knowing if they’re being used effectively, if at all. InSee will change that and I’m thrilled that the FDA has recognized InSee’s utility.”
