Fayetteville, AR – July 8, 2025 – Enhance Diagnostics, a clinical-stage company focused on non-invasive diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its flagship product, Breeze™, a novel breath-based diagnostic platform designed for patients diagnosed with a urea cycle disorder (UCD).
Breeze is an innovative point-of-care device indicated for the measurement of ammonia in exhaled breath. The test provides rapid, non-invasive detection of hyperammonemia, a serious and potentially life-threatening complication of UCDs. Designed for both home use and clinical settings, Breeze aims to support real-time clinical decision-making by patients and healthcare providers, offering earlier detection and improved management of elevated ammonia levels. Future applications of the Breeze platform include monitoring patients with chronic kidney disease (CKD) and acute kidney injury (AKI), to monitor disease progression and clinical deterioration.
In response to the news, Chief Scientific Officer, Matthew Leming, PhD, said “Receiving Breakthrough Device Designation from the FDA is a significant milestone for Enhance Diagnostics and the UCD patients we aim to serve. This designation underscores the urgent clinical need for innovative tools to monitor patients more effectively, in particular, outside of the hospital setting. We are proud to advance a technology that has the potential to transform care for this vulnerable population." The FDA’s Breakthrough Devices Program is intended to expedite the development and review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation will allow Enhance Diagnostics prioritized FDA review and interactive communication throughout the development process.
To learn more about Enhance Diagnostics, visit enhancediagnostics.com
About VIC Tech
Enhance Diagnostics is part of the VIC Tech portfolio. A venture studio focused on creating companies from innovative academic research. Breeze is the third device from a VIC Tech portfolio company to receive Breakthrough Device Designation from the FDA, highlighting VIC’s consistent track record of advancing impactful health technologies toward clinical and commercial success.