You might call
it an early Christmas present.
in my previous iBot update, the FDA held a hearing on December 12 to consider
DEKA’s petition to change the iBot medical classification. As I wrote in that post:
“…The iBot
needs a new manufacturer. But first, the regulatory environment must be
improved. DEKA initiated an application to have the FDA modify the status of
the iBot from a Class III medical device to Class II medical device. This would
significantly reduce the regulatory burden on the product…On December 12 a team
from DEKA will meet with the FDA Medical Devices Advisory Committee (it would
have been sooner but for the government shutdown)…If (the application) is
eventually approved, DEKA will be in a stronger position to recruit new
manufacturing partners.”
Department of Health and Human Services meeting notes:
“…the
panelists recommended a Class II designation for stair-climbing wheelchairs…”
major regulatory impediments making it difficult for the iBot to be
commercially viable. First, there was the Class III to Class II issue, which is
apparently behind us. Second, there is the fact that Medicare will not
reimburse patients for the iBot wheelchair. I don’t hold out
much hope for changing the Medicare issue in the near future, but maybe I’m wrong.
changing the iBot from a Class III device to Class II Device, a potential
manufacturing partner could relatively easily improve
the iBot in a number of ways, and make it more marketable to more users.
Perhaps these improvements could eventually make it so that Medicare
would reimburse patients.
DEKA, with an assist from Huey 091, is recruiting potential manufacturing
partners, and what happened on December 12 in Washington can only make the iBot
a more appealing venture. Hopefully, this will be enough to lure in somebody.
Maybe there was a group waiting in the wings and they will come forward soon
because of this decision. It’s more likely that DEKA still has a lot of work to
do, but they now have a better case to make with these companies.
deal is this decision? That remains to be seen. Perhaps it was too little too
late, or perhaps it was just what the doctor ordered. Only time will tell which
of these two clichés will apply.
of Alan Brown’s public testimony before the panel. Alan is an iBot user and a
member of the Board of Directors for the Christopher and Dana Reeve Foundation.
He is a strong advocate for the iBot and for wheelchair users in general, and a
gifted public speaker. Please watch and enjoy.
If you’re reading this through email click here to watch the video at YouTube.
Thanks for the update as I've been curious.
Very glad that progress towards saving the iBot has been made!
Wahooooo! Great news!
Darren and Daphne, I don't know what it is exactly, but it is something!