Tissue Regeneration gets FDA OK for 3D-printed cranial reconstruction device

09/3/2013 | MassDevice.com (Boston)

The FDA has cleared Tissue Regeneration Systems to market its Cranial Bone Void Filler, a 3D-printed cranial reconstruction device used to close holes in the skulls of patients who have undergone surgery. "To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing," said Jim Fitzsimmons, the company's president and CEO.

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