Curing with Sound
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Ep56: Demystifying the Regulatory Landscape with Matt Myers, PhD

Dela

In this episode of Curing with Sound, we speak with Matt Myers, PhD, a research physicist and founder of Puente Translational Sciences. Dr. Myers spent more than 30 years at the U.S. Food and Drug Administration (FDA), where he helped develop tools to evaluate emerging devices and applications, including focused ultrasound. Drawing on decades of experience, Dr. Myers offers an insider's perspective on the FDA's role in advancing medical innovation and explains how researchers and device developers can work more effectively with regulators to accelerate patient access to new therapies.

He discusses his early involvement with the first focused ultrasound submission for uterine fibroids, his important work during the COVID-19 pandemic, and his current efforts to help researchers and manufacturers accelerate the path to market for therapeutic ultrasound devices.

Discussion highlights:

  • Working with the FDA: How the FDA collaborates with researchers and manufacturers to improve devices, streamline regulatory pathways, and help bring safe and effective technologies to patients.
  • The Evolving Field of Neuromodulation: Why focused ultrasound neuromodulation is generating growing regulatory interest, and how standardized reporting will strengthen future research and clinical translation.
  • Preparing the Next Generation: Dr. Myers' advice for early-career researchers on developing the technical skills and interdisciplinary expertise needed to succeed in the rapidly evolving field of therapeutic ultrasound.

EPISODE TRANSCRIPT

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