7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Cranial Module.
| 7D Surgical announced today that it 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 innovative 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. “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 healthcare 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.) About 7D Surgical 7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, and similar benefits for its newly FDA 510(k)-cleared Cranial Application. The underlying technology provides the promise of similar future advancements for other surgical specialties. Contact: Forward-looking Statements This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. “Flash™,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical. View original content with multimedia:http://www.prnewswire.com/news-releases/7d-surgical-receives-fda-approval-for-cranial-surgery-300695706.html SOURCE 7D Surgical |
