Autonomix Medical Completes Pre-Submission Meeting With FDA For Its Transvascular Sensing Platform

Autonomix Medical, Inc. (NASDAQ: AMIX) has successfully completed a pre-submission meeting with the FDA for its standalone transvascular sensing platform, which aims to detect faint biological signals. The meeting provided guidance on the regulatory strategy and validation activities, with the company identifying a Class II regulatory pathway using a cleared reference device. If development and validation are successful, Autonomix is targeting potential U.S. clearance in approximately 15 months.