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Vesalio announces US FDA 510(k) clearance of pVasc NET
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Fusion42 · 13 August 2026 · Fusion42 review
Vesalio received FDA 510(k) clearance for pVasc NET, a peripheral mechanical thrombectomy device with an integrated distal filter designed to improve clot fragment capture during procedures.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it.
◆ ◆ The Wire takeaway
Medtech founders focusing on peripheral thrombectomy must pitch the improved clot capture of pVasc NET to enter or expand in the US market. Your device design now faces a higher standard for integrating safety features like clot retention.
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3 sources · 13 Aug 2026
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