Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and connected home-use spirometer device.
According to the FDA’s premarket notification database, the Stockholm, Sweden-based company submitted its application in November 2018, and received the decision last Thursday.
The Air Next is designed for patients with asthma, COPD or cystic fibrosis. After connecting to users’ iOS and Android devices via Blutooth LE, it conducts forced vital capacity and forced expiratory volume tests simultaneously. Data collected can be synced and shared with a patient’s care team. The product hit European markets in the spring of 2018, when it received a CE Mark as a Class IIa medical device.
MobiHealthNews has reached out to NuvoAir for comment on the regulatory clearance, and will update this story with any response from the company on its US plans.
WHY IT MATTERS
NuvoAir has mentioned international expansion plans in the past, and this 510(k) provides the company an opportunity to bring its digital respiratory health platform to US patients. With a new at-home tool for managing their conditions, these patients may be able to better track the progression of their disease and, as a result, more appropriately seek in-person care.
THE LARGER TREND
In April last year, NuvoAir closed $3 million in a funding round led by Industrifonden, with participation from Investment AB Spiltan, to grow its team and enter new markets. And just the other week it announced a new partnership with Roche Italy that would make its platform available to cystic fibrosis centers in the country.
But the connected respiratory health space is a busy one. Competition for NuvoAir includes Propeller Health, which is known for its connected inhaler and was not too far back was acquired by ResMed for $225 million.