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Medical Devices / Submissions and Approvals

Cohero Health Gains FDA Approval for Mobile Spirometer

June 4, 2015

Cohero Health’s mobile spirometer has won FDA 510(k) clearance, the New York City-based devicemaker announced Tuesday.

The handheld, wireless device measures critical lung function metrics. When paired with a smart phone or tablet, the product works in tandem with Cohero’s mobile asthma and chronic obstructive pulmonary disease management platforms.

These platforms feature sensors joined to maintenance and rescue medication and mobile apps that record medication use. The spirometer motivates, reminds and rewards patients who adhere to their prescribed medications.

The devicemaker claims it is the first to market an integrated connected health platform that both measures lung function and tracks medication use.

In the U.S., 50 million people are afflicted with asthma and COPD, with the number on the rise. — Jason Scott