Re: PMA in modules. Somewhere, back maybe a hundred posts, is a link to the relevant FDA regs. Essentially the company submits a chapter at a time, which is reviewed and approved for completeness, etc. Five mods in total.
The two significant ones they haven't even submitted yet relate to testing.
They have submitted three mods, two reviewed and approved.
At the end of the whole process, if each mod is OK, FDA does a once-over internal consistency review, and your wonder widget has the stamp of approval.
I suspect they are further away than they might have one believe. The infra-red detection technology is pretty garden variety, and yes nasty bad breast tumors throw out more heat than healthy tissue. There doesn't appear to be anything particularly unique about the basic hardware - there are some appurtenances like the exam table, temp-controlled exam room, etc.
It looks like the real key will be in developing predictive software algorithms that can make sense out of the raw IR data. Notice yesterday they got around to hiring a guy for this job. Building effective software to work with the hardware on soft tissue won't be a simple task. This is tricky business. A false diagnosis either way in cancer has some ugly ramifications. ("Sorry about removing your breast ma'am - it sure looked hot on our machine" or "Sorry about losing your wife, sir, I guess that little lump was worth worrying about after all.")
Secord would be quite familiar with the IR stuff from his days in the military - and guessing Packer might have worked on it somewhat if he was in the aerospace section of TRW.
There will be one more good PR just b/4 the distribution phase (aka "dump") begins in earnest, IMO.
The Raging Bull folk are having quite a party tonight, hear tell. Guess we're too serious over at SI. Later. |
