Respiratory Health company AireHealth lands 510(k) for connected nebulizer

AireHealth, a Floridian startup focused on the respiratory health space, landed an FDA 501(k) clearance […]

AireHealth, a Floridian startup focused on the respiratory health space, landed an FDA 501(k) clearance for its connected nebulizer VitalMed. The device was previously cleared as a stand-alone tool but did not have a connected component, according to the company.

The portable device is made of electronic vibrating mesh and is designed to nebulize medication for the inhaler at home. Patients will be able to connect the tool to a corresponding app, called VitalCompanion, which can track a patient’s symptoms, support their adherence efforts and connect to providers. In the future the company plans on adding a connected spirometer to the suite.

This FDA clearance comes about six months after it announced that it purchased fellow respiratory health company BreathResearch, acquiring the former’s IP, research and patents, including work on machine learning analytics for respiratory condition tracking.


Respiratory conditions are common in the United States. In fact, according to the CDC, 19.2 million adults in the U.S. have asthma. Today we’ve seen an uptick of companies and innovators looking to tackle respiratory health management by applying digital tools to help patients keep track of their conditions and understand their treatment better.

“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,” said Rebecca Shanahan, AireHealth’s interim CEO.

“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.”


This isn’t the only company applying digital tools to the respiratory health space. Teva Pharmaceuticals has been working on connected devices for some time. Over the summer it launched its ProAir Digihaler in the United States. The sensor-enabled albuterol dispenser can be used for multiple diseases, including asthma, COPD and the prevention of exercise-induced bronchospasm (EIB).

Propeller is another big name in the respiratory health space. This year the company scored FDA clearance for a sensor and app intended for use with AstraZeneca’s Symbicort inhaler for asthma and COPD.

Even Apple has shown interested in the area. In 2019 it reportedly bought respiratory health company Tueo Health.

Original Article: (