• Navigating FDA clinical trials in Neurotech with Tim Marjenin

  • 2024/08/23
  • 再生時間： 41 分
  • ポッドキャスト

Navigating FDA clinical trials in Neurotech with Tim Marjenin

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  • Greg and Matias interview Tim Marjenin, a regulatory consultant at MCRA with 16 years of experience at the FDA, to discuss the regulatory landscape for neurotechnology devices.

    Tim provides insights into the FDA approval process for neurotech devices, drawing from his extensive experience on the FDA's Neurostimulation-Neurology Devices Team. The episode explores the evolving field of neurotechnology and its regulatory challenges.

    In this episode, we discuss:

    • Different regulatory pathways for neurological devices (510(k), De Novo, PMA)
    • FDA's approach to novel neurotechnologies like brain-computer interfaces (BCIs)
    • Considerations for invasive vs. non-invasive neurotech devices
    • The importance of cybersecurity in neurotechnology
    • Common mistakes companies make in the regulatory process and how to avoid them
    • The potential future of neurotechnology, including human augmentation and telepathy

    Created by Greg Kubin and Matias Serebrinsky
    Host: Matias Serebrinsky & Greg Kubin
    Produced by Jonathan A. Davis, Nico V. Rey & Caitlin Ner

    Find us at businesstrip.fm and psymed.ventures
    Follow us on Instagram and Twitter!
    Theme music by Dorian Love
    Additional Music: Distant Daze by Zack Frank and Krotoa by Makropulos
    続きを読む 一部表示

あらすじ・解説

Greg and Matias interview Tim Marjenin, a regulatory consultant at MCRA with 16 years of experience at the FDA, to discuss the regulatory landscape for neurotechnology devices.

Tim provides insights into the FDA approval process for neurotech devices, drawing from his extensive experience on the FDA's Neurostimulation-Neurology Devices Team. The episode explores the evolving field of neurotechnology and its regulatory challenges.

In this episode, we discuss:

  • Different regulatory pathways for neurological devices (510(k), De Novo, PMA)
  • FDA's approach to novel neurotechnologies like brain-computer interfaces (BCIs)
  • Considerations for invasive vs. non-invasive neurotech devices
  • The importance of cybersecurity in neurotechnology
  • Common mistakes companies make in the regulatory process and how to avoid them
  • The potential future of neurotechnology, including human augmentation and telepathy

Created by Greg Kubin and Matias Serebrinsky
Host: Matias Serebrinsky & Greg Kubin
Produced by Jonathan A. Davis, Nico V. Rey & Caitlin Ner

Find us at businesstrip.fm and psymed.ventures
Follow us on Instagram and Twitter!
Theme music by Dorian Love
Additional Music: Distant Daze by Zack Frank and Krotoa by Makropulos
続きを読む 一部表示

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