I've emailed Copan marketing to ask.
I couldn't find any pending FDA applications, let alone approvals for the Phenomatrix product. Could be that they are trying their luck and claiming the software is just an upgrade to an existing, approved device.
Whatever the case, as others here have pointed out previously, the APAS Independence will occupy a different niche to Copan's and BD's offerings.
Why the hype?, page-108
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