A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed.
Regulatory News Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting On 6 and 7 November, FDA medical devices advisory committee will meet to discuss the use of [...]
Simbex’s NIH-Funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) program was named a winner of the U.S. Small Business Administration’s 2019 Growth [...]
FDA Issues Over 12 Major Medical Device Guidances in a Month and AI gets its First Procedural Billing Code
Regulatory News De Novo Requests: FDA Finalizes Three Guidances FDA finalized three guidance documents related to de novo classification requests for medical devices. The first guidance deals [...]