Autonomix Medical, Inc. announced on December 19, 2024, the appointment of a Vice President of Regulatory Affairs and Quality. This strategic hire is a key step in building the necessary team and infrastructure to support the company's clinical and regulatory initiatives.
The new executive brings expertise in biotech and medical devices, which is crucial for navigating the complex FDA approval process for Autonomix's first-in-class catheter-based sensing technology. This appointment underscores the company's commitment to its U.S. market strategy.
Autonomix remains on track to submit an Investigational Device Exemption (IDE) and, if approved, commence a pivotal clinical trial in 2025. This trial is intended to support a De Novo application for FDA approval, making the regulatory and quality leadership critical for success.
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