MGC Diagnostics Completes EU Registration and CE Marking for Fenom Flo™

Regulatory milestone clears the way for the company's FeNO testing platform to reach clinicians beyond the U.S.

St. Paul, MN, August 25, 2026 - MGC Diagnostics is proud to announce that Fenom Flo™, its fractional exhaled nitric oxide (FeNO) testing device has completed EU registration and CE marking, clearing the way for an expansion toward global availability. The milestone builds on Fenom Flo's U.S. launch earlier this year.

"Earning CE mark for Fenom Flo™ is a significant milestone, not just for this product, but for MGC's presence in respiratory diagnostics worldwide," said Raul Carreras, President of MGC Diagnostics. "FeNO testing gives clinicians an objective, evidence-based way to assess airway inflammation in asthma care, and Fenom Flo™ makes that testing easier to fit into everyday clinical workflow. CE Marking is an important step toward bringing this handheld device to more clinicians and patients worldwide."

About Fenom Flo

Fenom Flo™ is a handheld, point-of-care system that measures fractional exhaled nitric oxide, a recognized biomarker of airway inflammation used to support the diagnosis and ongoing management of asthma. Designed for use across a range of clinical settings - from specialty allergy and pulmonology practices to broader primary care - Fenom Flo™ delivers objective, repeatable results through a simple breath maneuver, without disrupting clinical workflow.

For more information about Fenom Flo™ or to request a demonstration, visit https://mgcdiagnostics.com/products/fenom-flo

About MGC Diagnostics

Founded in 1977 and headquartered in St. Paul, Minnesota, MGC Diagnostics is a leading provider of cardiorespiratory diagnostic solutions, known for its innovative technologies and superior customer support in the detection, diagnosis, and management of respiratory conditions. The company's product portfolio spans pulmonary function testing, cardiopulmonary exercise testing, body plethysmography, and FeNO testing, including Fenom Flo™. Its Ascent™ software platform - the most advanced cardiorespiratory software on the market - connects that data into one diagnostic ecosystem, simplifying clinical workflows and helping care teams manage patients with confidence.