Autonomix Medical adds ex-Medtronic regulatory counsel to its board
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Autonomix Medical, Inc. (NASDAQ: AMIX) has appointed Sandra Cohen Kalter, former Vice President and Chief Regulatory Counsel of Medtronic plc, to its board of directors, according to a press release from the medical device company.
Kalter spent 20 years at Medtronic in senior legal and regulatory leadership roles, where she advised business units on FDA strategy, clinical and legal regulatory matters, and product development. During her tenure, she oversaw due diligence and integration activities for more than 27 acquisitions. Her work at Medtronic included regulatory and strategic involvement with the Symplicity Spyral Renal Denervation system, Evolut TAVR platform, Micra Transcatheter Pacing System, and PulseSelect Pulsed Field Ablation system.
Prior to Medtronic, Kalter spent 13 years as FDA/Healthcare Counsel at King & Spalding LLP, where she advised clients on FDA regulatory matters including regulatory filings and FDA advisory panel proceedings. She holds a Juris Doctor from The George Washington University National Law Center and a Bachelor of Science in Journalism from Northwestern University.
"Her firsthand understanding of how a global medical device leader evaluates emerging technologies, navigates regulatory pathways and approaches strategic partnerships and acquisitions is exceptionally valuable to Autonomix," said Walter Klemp, Chairman of the Board of Autonomix.
Autonomix is developing a catheter-based microchip sensing array intended to detect and differentiate neural signals. The company's technology remains investigational and has not been cleared for marketing in the United States.
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