News

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, [...]

Ian Wood has been working with Simbex as a Summer 2019 Marketing Co-op.  

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 [...]

Josh Posen has been working with Simbex as a Summer/Fall 2019 Product R&D Co-op. 

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 [...]

Regulatory News Sharpless Outlines FDA’s Key Priorities for Advancing Public Health Acting FDA Commissioner Ned Sharpless sent an email to FDA staff outlining four main priority areas: assuring [...]

Regulatory News EC Cautions on MDR/IVDR Impact on Device Availability The European Commission acknowledged that the EU’s MDR and IVDR “could have consequences for the availability of medical [...]

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