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BD Biosciences is launching its FACSPresto Near Patient CD4 Counter System in CE mark countries after receiving authorization March 28, the company said Thursday. Read More
Austen BioInnovation Institute of Akron is teaming up with Cleveland’s Nottingham Spirk to hasten biomedical innovation in Ohio, the groups announced Monday. Read More
Florida’s RTI Surgical is launching its Streamline OCT spinal fusion system in the U.S. after receiving 510(k) clearance last month, the company said Monday. Read More
The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More