Acera Surgical Receives FDA Clearance for Nanofabricated Tissue Scaffold

Acera Surgical, Inc., a Washington University startup co-founded by former WU student Dr. Matthew MacEwan, received 510(k) clearance from the Food and Drug Administration (FDA) for its first clinical product, the Cerafix® Dura Substitute.

With the approval from the FDA, Cerafix® is the first nanofabricated tissue scaffold approved for clinical use in the United States.  Cerafix® is indicated for the repair of the dura mater following routine neurosurgical procedures. It is presently used by numerous top academic neurosurgical clinics around the country.

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