http://www.natlawreview.com/article/major-fda-reform-bill-becomes-law-medical-device-overview
New laws passed in December 13 show that the US FDA really do have AI technology on its mind. This set of new laws was meant to make it easier to market health/medical equipment and software in the US by exempting certain types from requiring approval.
Of particular interest to LBT would be Section 3060 of the new laws. In here, it says:
There you go. APAS FDA approval must have worked it's way into this new law, for them to actually specify such a type of software to be NOT exempt from approval. Don't forget, APAS made the FDA create a whole new category of approval for it.
- For transferring, storing, converting formats or displaying (but not interpreting) clinical laboratory tests or other device data and results, findings by a healthcare professional with respect to such data and results, general information about such findings, and general background information about such laboratory tests or other devices
More importantly, I'm fairly certain some of the APAS competitor products would've pinned their hopes on being exempt from approval as a result of this new law. Now that it's been confirmed that interpretive software does need approval, that makes us the only ones with the approval!!
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