Product News: Molzym announces FDA Breakthrough Device Designation for its molecular diagnostic test system
FDA Breakthrough Device Designation for Sepsis, Joint & Implant Infections, Infective Endocarditis, Bacterial Meningitis
13 May 2021
Molzym’ s unique technology for molecular microbial diagnostics was granted Breakthrough Device Designation (BDD) by the FDA in light of its capacity to aid the diagnosis of Bloodstream Infection/Sepsis, Joint and Implant Infections, Infective Endocarditis, and Bacterial Meningitis as an adjunct to the current standard of care.
The FDA BDD Program aims at providing patients and health care providers with timely access to these breakthrough medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval. Under the BDD, the FDA will provide Molzym with interactive communication and priority review towards commercialization decisions.