HORSHAM, PA — Biocoat Incorporated recenlty announced that its HYDAK® UV coating is now being used on two medical devices that have been awarded FDA 510(k) clearance status.
The first interventional device using HYDAK UV that received the 510(k) clearance is a neurovascular thrombus retriever catheter. The second device is an interventional use catheter designed to remove thrombus from the peripheral vasculature. Biocoat launched its UV cure coating in 2020 and these are the first two devices to receive FDA clearance using this unique, patented formulation.
“We are proud partners with our clients who have chosen to use HYDAK UV coatings for their cutting-edge interventional projects,” said Jim Moran, President & CEO, Biocoat. “The design and engineering teams from both organizations have collaborated closely to deliver the best coating design to maximize performance on their unique device. In addition, one of the companies will be using Biocoat’s in-house cGMP coating services to apply HYDAK UV to their finished medical device.”
Luke Marker, Managing Director for GTCR and a member of Biocoat’s Board of Directors stated, “Biocoat’s HYDAK UV technology was launched in 2020, received a patent in 2022 and is now included on two new devices in the market. The Biocoat team has done an exceptional job in developing a coating that supports progressive catheter designs.”
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