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  • Regulatory NewsRegulatory News

    EMA Seeks Input on First Guidance for Autism Treatments

    The European Medicines Agency (EMA) on Friday released its first guidance to help drugmakers develop therapies to treat autism spectrum disorder (ASD). The draft guideline seeks to provide advice on four critical areas of clinical development: diagnosis and inclusion criteria for patient selection in clinical trials, methods for assessing efficacy, clinical trial design and measuring drug safety. Currently, ASD treatment focuses primarily on behavioral therapy and speci...
  • FCC Regulation Aims to Promote Medical Device Innovation

    • 30 April 2013
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    A new regulation published by the Federal Communications Commission (FCC) would serve to streamline the Experimental Radio Service (ERS), a block of radio spectrum meant to promote innovation, including its medical testing license, now used in some medical device products. Background The ERS is basically a set of rules that "prescribe the manner in which the radio spectrum may be made available to manufacturers, inventors, entrepreneurs and students to experiment with n...
  • Report Highlights Potential Impact of Spectrum Changes on Medical Device Innovation

    • 23 July 2012
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    A new report out by the President's Council of Advisors on Science and Technology (PCAST) makes the case that blocks of carefully managed wireless spectrum may be of increasing importance to future medical device innovation. The report, Realizing the Full Potential of Government-Held Spectrum to Spur Economic Growth , comes just two months after the Federal Communication Commission (FCC) announced its own first-in-the-world plan to dedicate a band of wireless spectrum...
  • FCC Approves First-in-World Plan to Dedicate Spectrum to Networked Medical Devices

    • 24 May 2012
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    In an expected move, the Federal Communications Commission (FCC) approved a plan to dedicate a new band of shared spectrum to an emerging class of medical devices known as Medical Body Area Networks (MBANS). MBANS are effectively networks composed of multiple wireless medical devices capable of communicating with one another. FCC had been publicly touting its intent to dedicate the 2360-2400 MHz spectrum band to the emerging MBAN device class since at least April 2012....
  • FCC Unveils Plan to Release New Spectrum for Wireless Medical Devices

    The Federal Communication Commission's (FCC) Chairman, Julius Genachowski, unveiled a plan to release new wireless spectrum to support the development of Medical Body Area Networks (MBANs), saying the new spectrum will help advance patient safety and device innovation. Under the plan, MBANs, or networks composed of multiple wireless medical devices capable of communicating with one another, will be bolstered by a "multi-track mobile action plan to free up more spectrum f...
  • FCC Pushing to Release New Spectrum for Medical Devices

    The US Federal Communications Commission's (FCC) Chairman, Julius Genachowsky, is planning to deliver remarks at an event on 17 May where he will advocate releasing new wireless spectrum to support Medical Body Area Networks (MBANs)-networks composed of multiple medical devices capable of communicating with one another. As Scientific American reported in 2009 , "an MBAN would help hospitals and healthcare clinics better keep tabs on important health-related informatio...
  • FCC Unveils New Spectrum for Implantable Neuromuscular Microstimulation Devices

    • 27 January 2012
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    The US Federal Communications Commission (FCC) released new regulations on 27 January that opens up the existing Medical Device Radiocommunication (MedRadio) Service spectrum to allow medical implant devices employing neuromuscular microstimulation (MMN) techniques to use the spectrum. The Regulation, Additional Spectrum for the Medical Device Radiocommunication Service , is "part of a larger effort to recognize and facilitate the significant advances in wireless medi...