Vyriad Signs Exclusive License Agreement for STING Technology August 5, 2016 Vyriad will use this encoding for their device for the treatment of advanced cancer. Read More
Seegene Debuts Automated Development for Molecular Testing Devices August 3, 2016 Seegene has found a way to simplify the process of real-time PCR assay development. Read More
FDA Approves Medtronic’s Artificial Cervical Disc July 25, 2016 Prestige LP disc shows promise compared to fusion surgery in U.S. markets. Read More
FDA Grants Emergency Use Authorization to Viracor-IBT for Zika Virus Test July 22, 2016 Molecular diagnostic tool detects RNA in fluids for the Zika virus. Read More
LifeBond Scores IDE Approval for LifeSeal July 21, 2016 The sealant gained CE mark approval in April. Read More
Study Affirms Safety and Efficacy of Flex Robotic System July 19, 2016 Treatment was successful in 91 percent of transoral procedures. Read More
Guidance Maps Out Codevelopment Pathways for Companion Diagnostics, Drugs July 19, 2016 The guidance describes general principles to guide codevelopment. Read More
Essential Medical Gains IDE Approval for Manta Clinical Study July 12, 2016 The study will assess the safety and efficacy of the vascular access closure device. Read More
John Sheets Tapped as New Director of ODE June 27, 2016 Sheets began his new duties on June 12. Read More
Draft Guidance Spells Out Strategy to Increase Diversity in Clinical Trials June 27, 2016 The agency outlines what demographic variables should be considered in study designs. Read More
FDA Lays Down Roadmap for Extrapolating Adult Clinical Data for Pediatric Use June 27, 2016 The agency clarifies how and when existing adult clinical data may be extrapolated. Read More
First Patients Treated With CorMatrix Tyke June 22, 2016 The product gained FDA clearance last February. Read More