They've been using that statement for years. They have to make that distinction (or disclaimer) because their "product" has not been cleared by the FDA. BEFORE they can draft a PMA for submission to the FDA they first have to run external clinical trials and internal validation studies. To the best of my knowledge (since they don't respond to questions) they have yet to begin this necessary testing - which can take >1 year to conduct and cost in the millions of dollars. Nothing indicates that they are taking steps to do this work. IF they ever did undertake this significant effort, and complete all of the required testing, it will likley take another 12-18 months for FDA clearance before they can sell in the US. And that's assuming the FDA doesn't ask for any additional information or data (very unlikely). Not one of their new hires have mentioned anything about doing what's necessary to sell in the US. That doesn't seem to be in their plans.
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