The U.S. Food and Drug Administration has awarded breakthrough device designation to Hemex Health for its Gazelle® Hb Variant Test, a diagnostic platform designed to rapidly detect hemoglobin disorders using miniaturized electrophoresis technology.

The Gazelle® platform separates and identifies hemoglobin fractions and variants, potentially enabling healthcare providers to diagnose blood disorders at the point of care rather than sending samples to centralized laboratories. The technology aims to make hemoglobin testing more accessible in decentralized healthcare settings.

FDA Breakthrough Program Activity

The designation comes as the FDA's breakthrough device program maintains steady activity entering fiscal year 2026. According to regulatory data, orthopedics emerged as the most active therapeutic area in the second half of 2025, with the agency issuing 13 breakthrough designations to devices in that field. Other recent breakthrough designations include Sonorous Neurovascular's BosSTENT device for treating pulsatile tinnitus caused by venous sinus stenosis, and BioCardia's advancement of its Helix catheter under the CardiAMP Cell Therapy System designation.

The FDA's breakthrough device designation is reserved for medical technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The program aims to expedite the development and review process for devices that address unmet medical needs. Hemoglobin disorders, including sickle cell disease and thalassemia, affect millions of people worldwide and often require frequent monitoring and management.