Tic, Toc, Tic, Toc, Tic, Toc, we are not alone and need to get off our ass before we're run over. Time to change direction, and stop pissing into the wind. We don't need FDA we need exposure. Have a great day.
Did you click into the product part of this link? They are monstrously huge devices and they cost on average about $6,000 per unit. This technology has been around for some time in this size and cost. BIEL makes it small, wearable, and cost effective. Hard to compare the 2 here.