Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device

Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.

Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market.

Madorra’s handheld device is designed as a prescription, noninvasive home-use device that applies ultrasound waves along the vaginal canal to stimulate local heat and blood flow and produce natural vaginal lubrication to alleviate symptoms of vulvovaginal atrophy (VVA).

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Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device

Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.

Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market.

Madorra’s handheld device is designed as a prescription, noninvasive home-use device that applies ultrasound waves along the vaginal canal to stimulate local heat and blood flow and produce natural vaginal lubrication to alleviate symptoms of vulvovaginal atrophy (VVA).

“VVA is a silent condition under-discussed by society but for postmenopausal women it’s very real and impacts their lives,” Dr. Rodney Baber, a doctor at Royal North Shore Hospital in Sydney, said in a news release. “A majority of women in this trial who used the Madorra device experienced symptom relief and wanted to continue using the device…

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