Synergetics (SURG) Gets 510(k) Clearance from FDA for VersaVIT
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Synergetics USA, Inc. (Nasdaq: SURG), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT", a novel vitrectomy system for the retinal surgery market.
"The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics' strategy to enter into higher growth areas of retinal surgery," said David M. Hable, President and CEO. "We believe that VersaVIT is a 'game changer' given its functionality, portability and competitive pricing relative to traditional vitrectomy systems." The Company is awaiting CE mark approval, which has been submitted and is currently under review.
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"The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics' strategy to enter into higher growth areas of retinal surgery," said David M. Hable, President and CEO. "We believe that VersaVIT is a 'game changer' given its functionality, portability and competitive pricing relative to traditional vitrectomy systems." The Company is awaiting CE mark approval, which has been submitted and is currently under review.
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