Autonomix (AMIX) Targets FDA Class II Clearance for Sensing Platform in 15 Months

Autonomix Medical, Inc. (AMIX) said it completed a pre-submission meeting with the U.S. Food and Drug Administration regarding its standalone transvascular sensing platform and identified a Class II regulatory pathway. The company is targeting potential U.S. clearance in approximately 15 months, subject to development, validation activities, and FDA review. The platform is designed to detect and differentiate faint biological signals. Autonomix said it will pursue a substantial-equivalence strategy using an already-cleared reference device to support the submission. CEO Brad Hauser said the company looks forward to sharing more in the coming months about advancing these capabilities. The company plans to continue developing and validating the standalone sensing platform while working toward signal interpretation and other computational capabilities for future versions. AMIX has traded between $2.44 and $32.55 over the last year. The stock was up 0.93% at $3.811.