The Breakthrough Devices Program [1] is just a special review program. Designation just means you get to go through a non-standard approval process because your technology is too different to be well-served by the normal review process.

It is not a endorsement or approval of the technology. It is basically just approval to get faster responses from the FDA.

[1] https://www.fda.gov/medical-devices/how-study-and-market-you...