Regulatory News Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings in April 2020, FDA expects to publish a proposed rule on the modernization of the quality system [...]
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 [...]
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 [...]
Rick Greenwald has spent his life working towards making sports and medical devices safer. A couple weeks ago, our CEO, Rick Greenwald went on the Sydcast podcast to talk with Sydney Finkelstein, [...]
This month, we launched our new website for ActiveStep®. ActiveStep® is an instrumented treadmill that uses rapid belt movements to induce slips, trips, and falls. Based on over 25 years of [...]
Regulatory News US FDA medical device user fees increase six percent for 2020 FDA medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market [...]
