Bovie Medical Corp. (BVX) announced a CE Mark for its SEER tissue resection device intended for initial use in liver oncology surgery, allowing for the sale of the device in the European Union and all countries recognizing the CE Mark. The company will immediately commence shipping the SEER to customers in the EU through its previously established network of distributors.
Additionally, the company reported that it filed a 510(k) pre-market notification application to the U.S. Food and Drug Administration requesting regulatory clearance for the SEER.
Bovie Medical also received 510(k) clearance from the FDA to market its ICON GP generator to be used in general surgery and in conjunction with Bovie's Polarian vessel sealing instruments. As of this date, a 510K application has not been filed for the Polarian instruments.
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