FDA Clears Fenom Pro 6-second Test Mode - CAIRE Inc.
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Major Milestone for Expanded Access to FENO Testing in US

Pleasanton, CA, June 22, 2023 — CAIRE Diagnostics is pleased to announce that the Fenom Pro® can now be upgraded to include a 6-second test mode available for ages 6 and up.

The completed clearance (K213611) by the FDA this month marks a major milestone for testing fractional exhaled nitric oxide (FENO) in the US — giving broader access to accurate clinical data for individuals with inflamed airways for patients ages 6 and older.

The Fenom Pro is a FENO device used to detect allergic inflammation in asthmatic patients. Its Indication For Use differentiates the device from other options in the market that restrict 6-second test mode to ages 7–10. This new functionality on the Fenom Pro has been available on models outside of the US since 2019.

“The achievement of this indication for use is a giant leap forward in making FENO testing more comfortable for those patients who find the 10-second test challenging. Accurate data and a shortened test window are a win-win for the patient and clinician who is working to ensure they get the care they need to stay healthy,” said Ryan Leard, CAIRE Diagnostics Chief Operating Officer.

Watch a Fenom Pro Demonstration by clicking this box.

It is estimated that asthma affects more than 300 million individuals worldwide and the Global Initiative for Asthma (GINA) guidelines recommends FENO measurement as an assessment tool in the management of asthma patients.

FENO is directly associated with infiltration of eosinophils in the airways and is elevated in individuals with allergic asthma. FENO can be used in a supportive way to diagnose asthma, to detect nonadherence to inhaled corticosteroids (ICS), and is a great tool for ongoing asthma management.

To view the updated Fenom Pro Instructions For Use (Software Version 4.2 and later) and exact language on approved indications, please visit the website.

Providers wishing to schedule an upgrade to activate the 6-second test mode and/or the periodic service for their Fenom Pro device(s), please fill out the online contact form including device serial number(s), interest in the upgrade, and your urgency level for timing in the comments section.

CAIRE Diagnostics, a division of CAIRE Inc., is committed to creating broader access to FENO testing around the world, for all asthmatics, regardless of where they seek care.

Find out more about CAIRE Diagnostics and Fenom Pro at www.fenomasthma.com and https://www.caireinc.com/diagnostics/.

Ref: MKT-3880