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September 5, 2023
VVT Medical’s ScleroSafe System Receives FDA Clearance
September 5, 2023—VVT Medical, a medical device company headquartered in Israel, announced this summer that its ScleroSafe platform received FDA 510(k) clearance for nonthermal, nontumescent treatment and management of varicosities in superficial veins. The clearance paves the way for commercialization of the device in the United States, noted the company.
VVT Medical’s ScleroSafe has previously received approval in multiple regions, including Europe, Australia, Southeast Asia, and South America.
According to the company, ScleroSafe’s inverse-action dual syringe injects a sclerosing substance into the vein through one syringe while simultaneously aspirating blood and substance residuals through the second syringe within a single motion and with a single-handed operation.
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