QuickMIC® receives Breakthrough Device Designation from the U.S. Food and Drug Administration
The diagnostics company Gradientech today announces 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 or 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.
“We developed the QuickMIC system based on a breakthrough technology that makes it the fastest AST system for positive blood cultures. The technology also brings susceptibility testing to a completely new level in terms of precision and accuracy. To have the FDA recognise our QuickMIC system as a breakthrough device is therefore extremely rewarding and a very important step towards bringing QuickMIC to the US market,” says Sara Thorslund, co-founder and CEO of Gradientech.
The QuickMIC system and its Gram-negative panel are CE-marked and commercially available in Europe but not yet available for sale in the United States.
For further information, please contact:
Sara Thorslund, PhD, CEO
Tel: +46 736 29 35 80
About Gradientech
Gradientech is leading the field of ultra-rapid antibiotic susceptibility testing. We develop next-generation diagnostics in infectious disease medicine. Our product QuickMIC®, classified as a breakthrough device by the U.S. Food and Drug Administration, allows patients with sepsis to quickly receive specific guidance on the right antibiotic in the right dose. It saves lives, reduces healthcare costs and limits the spread of antibiotic resistance – one of the greatest global health threats of our time. Gradientech is headquartered in Uppsala, Sweden. Visit www.gradientech.se for more information.
