QuickMIC® receives Breakthrough Device Designation from the U.S. Food and Drug Administration
Gradientech is happy to announce that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Device Designation for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST). The Breakthrough Device Program is reserved for certain medical devices that provide more effective treatment or diagnosis than approved or cleared alternatives, and where the device availability is in the best interest of patients.
The Breakthrough Device Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment and the review for approval of clearance. With the breakthrough device designation, Gradientech is entitled to several advantages like timely communication with the FDA, interactive review of the clinical study plan and prioritised regulatory review of the final submission for FDA clearance.