fuente - your message has stimulated an interesting thought.
Call me naive, I am not expert at these things, but I was taught that there are very few stupid thoughts and fewer stupid questions that involve a provocative idea.
Drugs cure diseases, kill bacteria, devices do not - I believe you are correct. However I don't recall BIEL claiming its devices cure diseases. My understanding is that the company claims its devices reduce pain and promote healing, which is exactly what happened to me with a very badly sprained ankle. I had no disease, no infection; I sustained an injury (tennis) which required natural body tissue healing, not a cure.
In the case of ALLAY, does the company not promote its device as reducing pain, cramping and so on? Again, not a disease requiring a cure? However, the ripple effects of ALLAY seem to be huge - family, work, leisure, sleep, etc.
In the case of painkiller tablets, capsules, caplets, etc., etc., is it also not rue that they do not cure a thing, that they only mask pain? A good thing, but involving ingested chemicals.
So, the question that arose when I read your post is this. If BIEL's devices treat pain and therefor promote natural body tissue healing as alleged, just like chemical painkillers, might the BIEL devices potentially be overwhelming 'new' developments in total marketing and sales opposition of the chemical painkiller manufacturers and marketers? Might it also be logical to think that the FDA decision makers fully realize this potential and may simply wish/need to 'get it right' so the administration remains above reproach because of the potential impact? This seems to me to be a reasonable approach, given that BIEL already has FDA approval for its post-op eye device. As I said before, if I am J&J, I am looking at Biel as a potential acquisition target to get my hands on the strong IP protection of its patents.
