US FDA clears NuvoAir's connected spirometer device

"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..." Lire la suite