BioMérieux: Biofire Filmarray TF cleared by the FDA
(CercleFinance.com) - bioMérieux announces special 510(k) clearance from the US FDA for its Biofire Filmarray Tropical Fever (TF) panel, an innovative PCR test that enables rapid and accurate identification of pathogens in patients presenting with unexplained fever.
The symptoms of tropical fevers can be confused with those of other pathologies, making it difficult to distinguish between benign, self-limiting illnesses and more serious diseases requiring rapid, targeted treatment, the group says.
bioMérieux first plans to market the test in a number of identified countries, including the US, in Q1 2025. It will then be submitted for CE marking so that it can be registered and deployed in other countries worldwide.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The symptoms of tropical fevers can be confused with those of other pathologies, making it difficult to distinguish between benign, self-limiting illnesses and more serious diseases requiring rapid, targeted treatment, the group says.
bioMérieux first plans to market the test in a number of identified countries, including the US, in Q1 2025. It will then be submitted for CE marking so that it can be registered and deployed in other countries worldwide.
Copyright (c) 2024 CercleFinance.com. All rights reserved.