FDA grants clearance to Deerfield Imaging for SYMBIS Surgical System
Deerfield Imaging announced that the FDA has granted 510(k) clearance to its SYMBIS Surgical System. The clearance means that SYMBIS Surgical System, to be used for stereotactic brain biopsy, has been approved to be marketed in the United States.
“Developing a new image-guided neurosurgical robot is a big undertaking with many challenges,” Jay D. Miller, Deerfield Imaging president and CEO, said in a statement. “This is a major milestone and the result of commitment from our team to produce core technology upon which we believe future neurosurgical applications beyond biopsy can be built.”
Deerfield Imaging is a wholly owned business of Deerfield Management Company. Back in August, the company acquired “certain assets and liabilities” of IMRIS.
Deerfield Imaging also recently announced that Gregory Sorensen, MD, had been named the company’s new executive chairman.