IlluminOss Medical wins de novo nod from FDA for bone stabilization system (MassDevice)
MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA (press release)
The FDA last month granted de novo clearance to the photodynamic bone stabilization system developed by IlluminOss Medical.
The IlluminOss device uses a light-curable polymer, delivered in an expandable balloon catheter, to stabilize bone fractures. In a Dec. 19 letter to the East Providence, R.I.-based company, the FDA granted de novo clearance for an indication for “skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.”
The federal safety watchdog said it also concluded that the IlluminOss device is Class II, under the generic name in vivo cured intramedullary fixation rod. IlluminOss said it plans to have the device on the market during the second half of this year.
“The FDA marketing clearance marks a significant milestone for IlluminOss Medical, allowing us to bring our products to the U.S. market,” CTO Robert Rabiner said in prepared remarks. “The IlluminOss System was d...
