FDA 510(k) Clearance Program
Regulatory approval for U.S. market
Key Facts
About Gradientech
Gradientech is a commercial-stage diagnostics company addressing the critical need for faster antibiotic susceptibility testing, particularly in sepsis management. Its flagship product, the QuickMIC® system, leverages a proprietary microfluidics and live imaging platform to generate phenotypic MIC results with high precision in 2-4 hours, dramatically faster than traditional methods. The system is CE-marked for its Gram-negative panel in Europe and holds Breakthrough Device designation from the U.S. FDA, positioning it for significant impact in combating antimicrobial resistance and improving patient outcomes. The company is actively presenting data at major scientific conferences and expanding its commercial footprint.
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