Press release

AireHealth Announces FDA 510(k) Clearance of Connected Nebulizer for Patients with Respiratory Conditions

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Sponsored by Businesswire

AireHealth, an innovative digital health company empowering and improving healthy living through affordable treatments, symptom tracking and early detection of respiratory conditions, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its connected nebulizer. The device is a portable, electronic vibrating mesh nebulizer designed to nebulize liquid medications for inhalation by a patient in and out of the home. The nebulizer will be marketed and sold under the brand name VitalMed.

Early next year, the nebulizer will seamlessly connect to VitalCompanion, AireHealth’s new diary companion app designed to help patients track symptoms, receive support for medication adherence and enable real-time connections to their providers. In 2021, AireHealth will also add VitalCapacity, a connected spirometer, to its VitalBreath respiratory care platform.

“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.”

AireHealth recently completed an acquisition of BreathResearch to address the growing challenges in respiratory illness that cost more than $130 billion per year, and are the cause of nearly 50 deaths per 100,000 people. The acquisition has positioned AireHealth to integrate data collection and analysis capabilities into its connected respiratory care platform. By tracking symptoms, status, decline, interventions and outcomes, AireHealth can build data sets for clinical benchmarks, improve early detection of respiratory diseases and reduce high costs.

Learn more about AireHealth and how its connected nebulizer can support chronic care management and remote patient monitoring programs for healthcare providers.

About AireHealth

AireHealth is an innovative digital health company empowering and improving healthy living through affordable treatments, symptom tracking and early detection of respiratory conditions. With strong IP and clinically validated products in our pipeline, the company enables more proactive care and early interventions to improve outcomes and reduce costs.

The company provides monitored drug delivery through its FDA cleared Class II portable nebulizer, designed to deliver medicine directly to a patient’s lungs where it is most effective. AireHealth’s virtual care platform, VitalBreath powered by BreathResearch, allows for early detection of respiratory decline with the addition of respiratory testing and vital signs. The result is that patients not only take a more proactive approach to managing their respiratory care but allows for a faster response to exacerbations and fewer emergencies and hospitalizations, which helps achieve their goal of improving treatment outcomes and lowering costs. For more information, please visit Aire.Health.