FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Atlantic Therapeutics’ Transcutaneous Electrical Stimulator Cleared

Nov. 14, 2018

The FDA issued de novo clearance to Atlantic Therapeutics’ INNOVO therapy device, used to treat stress urinary incontinence.

The company’s transcutaneous electrical stimulator is the first device of its kind to be granted FDA approval.

INNOVO is a non-invasive, novel wearable device for women with stress urinary incontinence and is designed to be used at home.

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