Advisers to FDA approve iBot chair
GAITHERSBURG, Md. - The iBot, Johnson & Johnson’s stair-climbing power wheelchair, mounted another step on the way to market in November when an advisory panel to the FDA unanimously recommended approval of the new technology.
Independence Technologies, the J&J subsidiary that will distribute the iBot, is looking forward to 510(k) marketing clearance from the FDA in the March – May 2003 time frame. The iBot could start hitting the stairways 30-60 days later, according to an Independence spokesman.
“After decades of work, it looks like it’s finally paying off,” Dean Kamen, the well-known inventor who created the iBOT and licensed it to Johnson & Johnson, told the Associated Press in November.
Using an array of gyroscopes, sensors and lift mechanisms, the chair enables users to climb stairs and elevate themselves to a standing position. The price tag for the chair is expected to be $25,000 to $29,000.
Independence Technologies, the J&J subsidiary that will distribute the iBot, recently began advertising for sales reps with OT/PT backgrounds, a move which suggests the company plans to bypass the traditional rehab provider distribution channel when it begins selling the iBot.
But Independence says those plans have yet to be set in stone and will be revealed when the company launches the product.
The advisory panel’s recommendation to the FDA hinges on four conditions:
- Orders for the chair must come with a physician’s diagnoses and prescription.
- Users must receive training at a clinician’s test site and at home.
- The FDA must receive periodic reports of device failures and injuries.
- Clinicians must be appraised of future device changes so they can adjust training. HME