Hemex Health Receives FDA Breakthrough Device Designation for Gazelle® Hb Variant Test

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Hemex Health, a medical diagnostics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Gazelle® Hb Variant Test. The FDA's Breakthrough Devices Program is intended to expedite the development, assessment, and review of medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases.

Why it matters

The Breakthrough Device Designation reflects the FDA's recognition of the need for improved tools to support the management of sickle cell disease. The Gazelle® platform is designed to rapidly separate and detect hemoglobin fractions and variants, with the goal of enabling decentralized access to quantitative hemoglobin data, which could play a crucial role in supporting therapeutic monitoring and disease management in sickle cell disease and other hemoglobinopathies.

The details

Through the Breakthrough Devices Program, Hemex will receive prioritized interaction and feedback from the FDA as it advances development of the Gazelle Hb Variant Test. The Gazelle® platform uses miniaturized electrophoresis technology to rapidly separate and detect hemoglobin fractions and variants, with the aim of enabling decentralized access to quantitative hemoglobin data. Hemex is exploring the potential role of this technology in supporting therapeutic monitoring and disease management in sickle cell disease and other hemoglobinopathies.

• Hemex Health announced the FDA Breakthrough Device Designation on February 6, 2026.

What they’re saying

What’s next

Through the Breakthrough Devices Program, Hemex will receive prioritized interaction and feedback from the FDA as it advances development of the Gazelle Hb Variant Test.