Stockholm January 13th, 2020 – NuvoAir, a leading digital platform focused on improving the health of severe respiratory patients, announced today the U.S. Food and Drug Administration (FDA) has granted FDA 510(k) clearance for their Air Next spirometer. This spirometer is a simple handheld device that connects through Bluetooth.
“Today we are pleased to announce the FDA clearance of the Air Next spirometer, this is a stepping stone of our digital ecosystem that is coming to life” says Lorenzo Consoli, CEO and co-founder of NuvoAir. “This represents our first FDA clearance and will pave the way for our ambitious regulatory and commercialization roadmap in the US for a full suite of software and hardware products” continues Consoli.
The NuvoAir respiratory platform allows patients to perform a lung function and symptom assessment in the comfort of their own home. This data can be easily shared with their medical team and used by the patient to understand how their disease progresses over time. More importantly, this data can be accessed by doctors and physiotherapists at the hospital via NuvoAir’s digital platform to monitor their patients’ lung health. NuvoAir analytics can help predict worsening respiratory conditions, therefore medical professionals can then focus on their most critical cases to help optimize their workflow.
The NuvoAir respiratory platform is used across many hospitals in Europe to help patients with severe lung conditions such as cystic fibrosis, IPF, and severe asthma to achieve better respiratory health. NuvoAir technology is also successfully used to support Pharma companies and CROs in their clinical research efforts as well as to simplify the diagnostic process in a clinical setting.
To be closer to US customers, NuvoAir has opened an office in Boston.
Headquartered in Stockholm, Sweden, NuvoAir is a digital therapeutics company focused on enabling the right clinical decisions surrounding respiratory health in order to improve clinical outcomes.