This piece of legislation that has just been signed of by...

This piece of legislation that has just been signed of by President Obama (FDA Reform Bill) which gives the ability to expedite/place priority/slash red tape for FDA review procedures of 'breakthrough devices'.  One would think the AXP offering would fit nicely into the definitions below.

Section 3051 – Breakthrough Devices

Section 3051 of the act is titled “Breakthrough Devices” and authorizes the FDA to expedite the development of, and provide priority review for, breakthrough devices, which are defined as devices:
that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and
(A) that represent breakthrough technologies;
(B) for which no approved or cleared alternatives exist;
(C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
(D) the availability of which is in the best interest of patients.
Device firms may request designation under this section and the FDA must respond within 60 days of the request.