Home-Use Wireless Spirometer Gets FDA Clearance

The first full home-use spirometer has received 510(k) clearance from the Food and Drug Administration
The first full home-use spirometer has received 510(k) clearance from the Food and Drug Administration

The GoSpiro Home Spirometer, the first full home-use spirometer, has received 510(k) clearance from the Food and Drug Administration (FDA). The GoSpiro can wirelessly connect to smartphones, tablets or personal computers, and integrates with Monitored Therapeutic's ‘GoHome Patient Monitor', which gathers information and facilitates communication between physician and patient.

“The GoSpiro is the only spirometer currently on the market that has met the latest and more stringent ISO and FDA device requirements for home use,” said Michael Taylor, Chief Development Officer of Monitored Therapeutics. 

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The device can collect forced spirometry (FVC) and slow spirometry (SVC) with the same accuracy as hospital laboratory systems and provides immediate feedback to patients.

For more information visit Monitoredrx.net.