AireHealth gets 510(k) clearance for connected nebulizer

According to Florida-based startup AireHealth, the company has received 510(k) clearance from the FDA for its VitalMed connected portable vibrating mesh nebulizer. Earlier this year, AireHealth acquired BreathResearch and its VitalBreath virtual respiratory health monitoring platform. In 2021, the company said, the VitalMed nebulizer will connect to a new app called VitalCompanion.

AireHealth interim CEO Rebecca Shanahan commented, “Consumers facing chronic respiratory issues require care, resources and tools that integrate with their day-to-day lives, which is why the development of a connected platform to comprehensively address their needs is so vital. AireHealth is pleased to have received 510(k) clearance of our connected nebulizer from the FDA, which will support the creation of an overall ecosystem of connected solutions to treat patients with respiratory conditions.”

The company said that it also intends to introduce a connected spirometer called VitalCapacity sometime in 2021.

Read the AireHealth press release.

Share

published on

June 10SMI.London 2026, London, UK

July 13-July 162026 ISAM Congress, Taipei, Taiwan

September 15-September 18DDL New Researcher Network Summer Event, London, UK

September 16-September 17IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA