Breakthrough Status

FDA Designates Madorra’s Handheld Ultrasound Breakthrough Device

September 13, 2021

The FDA has granted Madorra breakthrough device designation for its noninvasive, home-use device for women experiencing moderate-to-severe vulvovaginal atrophy (VVA), a common condition associated with menopause.

The device, which applies therapeutic ultrasound waves along the vaginal canal, is intended to stimulate local heat and blood flow, producing natural lubrication to alleviate the condition.

The yet-to-be-named handheld device will be available by prescription, after undergoing a pivotal clinical trial, the Portland, Ore.-based company said.

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