Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device.
The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal.
WHY IT MATTERS
Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view this data remotely via a healthcare portal.
NuvoAir analytics help to assess changes in the respiratory status of each patient, enabling clinical teams to follow-up with their patients.
NuvoAir Home has been shown to support effective virtual healthcare consultations. The results of a recent survey conducted by the Cystic Fibrosis Center at Royal Brompton and Harefield NHS Trust showed that using NuvoAir Home combined with virtual consultations reduced the number of hospital visits over a six month period.
This could potentially lead to significant cost savings for both the patients and hospital and reduce the infection risk for this vulnerable population during the COVID-19 pandemic.
THE LARGER CONTEXT
In April 2018, NuvoAir unveiled its newest version of its home-use spirometer, dubbed the Air Next, which also received a CE Mark as a Class lla medical device.
Earlier this year, the company picked up its first FDA 510(k) for the spirometer device, which is designed for patients with asthma, COPD or cystic fibrosis.
Around the same time, the respiratory company partnered with Roche Italy to make its technology available in selected cystic fibrosis centres.
ON THE RECORD
Lorenzo Console, CEO of Stockholm-based NuvoAir, said: “This clearance is an important stepping stone in our journey to become the respiratory platform of choice for patients and physicians. By having the full platform cleared, NuvoAir can now expand its offering considerably to include other clinically relevant digital biomarkers, increasing our ability to understand when patients' respiratory health is deteriorating.”