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7D Surgical Receives FDA Approval for Cranial Surgery

7D Surgical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module. This achievement is a crucial step in the commercial launch of 7D Surgical’s Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery throughout the United States.

“The 7D Surgical System utilizes completely new camera-based technology and machine vision algorithms to eliminate the long-standing frustrations with legacy surgical navigational platforms. Using a completely contactless workflow, the MvIGS technology can acquire hundreds of thousands of virtual fiducials using the patient’s own anatomy. This results in a nearly instantaneous cranial registration in almost any surgical position,” according to a press release.

“We are incredibly excited to expand the MvIGS technology to cranial surgery. The speed, accuracy and efficiency of this new application, coupled with astounding workflow and safety improvements we have already introduced for spinal image guidance, has resulted in a very compelling and cost-effective solution for surgeons and hospitals. Faster, better and cheaper is the new mantra in health care and the 7D Surgical System is perfectly positioned to meet these goals,” said Beau Standish, chief executive officer of 7D Surgical.

The new Cranial Module can also register multiple datasets independently to the intra-operatively acquired Flashä registration. These new Linked Registrations allow surgeons to visualize the anatomy in virtually any modality on the fly, without the need for pre-planning and without the error propagation associated with traditional image fusion.

“This approval allows our team to offer new cranial functionality alongside our game changing spinal application to our existing and planned installations in the U.S.,” said Brian Stuart, vice president of sales and marketing of 7D Surgical.  “Hospitals have been asking us for cranial, and I am delighted to be able to offer this exciting application ahead of schedule and at a price point consistent with our value proposition.”

Ask for a demonstration of the new 7D Surgical Cranial Module at the North American Spine Society (NASS) annual meeting in Los Angeles, CA Sept. 26-28 (Booth 1249) or the Congress of Neurological Surgeons (CNS) annual meeting in Houston, TX Oct. 8-10 (Booth 1641.)



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