If my memory serves me correct (and that is a big IF at my age), years back the company did submit for ALLAY and did not get cleared. Keep in mind that was YEARS ago prior to FDA accepting real world data, as they eventually did for approving the knee and foot patch and will use for approving the 'back' and 'full clearance'. Also there was some talk of FDA needing more data due to the area of use so close to women's reproductive organs and the effect on pregnancies. Maybe these trials now will suffice. Again, don't trust my memory, but that is what I recall. I DO agree that this, if cleared, will be a huge seller.
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