IlluminOss wins “de novo” clearance for bone stabilization system with help from MCRA

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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 matu...

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