Historic FDA Clearance in Newly Established Category Signals a New Era of Female Led Innovation in Medical Technology LOUISVILLE, KY – (February 18, 2026) – As Women’s History Month approaches, Kentucky entrepreneur Alane Paulley is not just celebrating progress, she is defining it. In a medical device industry known for regulatory barriers and limited consumer access, Paulley has achieved a landmark breakthrough. Her female led company, AuraWell, has secured the first ever FDA clearance in a newly established over the counter frequency therapy category for its high-powered Aura Wave device. This historic decision makes clinical grade pulsed electromagnetic field technology available for home use without a prescription for the first time,…