Drug news
FDA grants De Novo clearance for Innovo device for the treatment of stress urinary incontinence.- Atlantic Therapeutics.
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced that the FDA has granted a DeNovo clearance for its Innovo therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females.
In its pivotal multi-centre randomized controlled clinical trial, 87.2% of Innovo users were dry or mild after a 12-week treatment period..
Comment: Innovo has a CE Mark.
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