FRANCE- BioMérieux has announced that its SPECIFIC REVEAL® Rapid Antimicrobial Susceptibility Test (AST) System has received the Breakthrough Device Designation from the U.S. Food and Drug Administration.
This designation is only given to medical devices that provide significant benefits over already-cleared alternatives, for which there are no approved alternatives, and/or whose availability is best for patients.
The goal of the program is to give patients and medical professionals prompt access to medical devices.
The Breakthrough Devices Program prioritizes the clearance review of medical technologies of public health concern while maintaining the statutory requirements for 510(k) clearance.
“I am very pleased to see the SPECIFIC REVEAL® System win this timely recognition,” said Paul A. Rhodes, Ph.D., founder, and former CEO of Specific Diagnostics.
She added that this will streamline the process for BioMérieux to bring hospitals across the United States a means to more rapid care for patients suffering from blood infections.
Through a variety of program choices, the Breakthrough Devices Program gives manufacturers the opportunity to engage with FDA experts in the field in order to effectively resolve issues as they come up during the premarket review process.
SPECIFIC REVEAL® Rapid AST System has been developed by Specific Diagnostics, a U.S. company acquired by bioMérieux in May 2022.
The System, which is already available in Europe under the CE-IVD (assay panel) and IVDR (instrument) designations, provides phenotypic antibiotic susceptibility test results in an average of 5.5 hours from the availability of positive blood culture.
This allows patients with bacteremic sepsis, one of the most rapidly progressing and life-threatening medical conditions, to make antibiotic decisions the same day.
According to FDA, Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Program’s objective is to expedite the development, evaluation, and review of breakthrough medical devices.
It does this while maintaining the legal requirements for premarket approval and De Novo marketing authorization, in line with the Agency’s mandate to safeguard and advance public health.
Through a variety of program choices, the Breakthrough Devices Program gives manufacturers the opportunity to engage with FDA experts in the field in order to effectively resolve issues as they come up during the premarket review process.
This helps manufacturers receive feedback from the FDA and identify areas of agreement in a timely way.
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