FDA clearance does not always translate into sales. And the FDA doesn't look at the studies that failed -- they only look at the studies submitted by the applicant.
The biotech highway is littered with companies that finally got FDA approval/clearance only to find that they couldn't sell their product.
The most damning piece of evidence against BIEL: they have FDA clearance and they've found ways to get the first device into consumers' hands, but they can't sustain revenues.
From a sales perspective, it's one-and-done. For a disposable product, that's bad.
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