We’re Officially FDA Cleared!

A Major Step Toward Enhancing Sepsis Diagnosis in Critical Care

 

We are proud to share a major milestone in our mission to transform diagnostic care: Abionic has received FDA 510(k) clearance for our revolutionary point-of-care diagnostic solution. This clearance marks a critical step forward in our efforts to bring ultra-rapid and accurate sepsis diagnostics to the U.S. market.

 

This achievement reflects years of tireless innovation, validation, and collaboration. With our nanofluidic technology now FDA cleared, we are poised to empower healthcare professionals across the United States with the ability to detect sepsis faster and more effectively, potentially saving thousands of lives each year.

 

Our U.S. expansion is now underway, and we couldn’t be more energized. We are grateful to our dedicated team, supportive partners, and visionary investors who helped make this possible.

 

But this is just the beginning. We remain committed to pushing boundaries in point-of-care diagnostics, and we’re excited to bring the benefits of our technology to clinicians and patients globally.

 

Stay tuned, 2025 is going to be a landmark year for Abionic.