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nanoMesh™ LLC (a subsidiary of Exogenesis Corporation) Announces Completion Filing of a Second Pre-Marketing Notification Application (510(k)) With The US Food and Drug Administration (FDA) nanoMesh™

Share this article Share this article BILLERICA, Mass., April 6, 2021 /PRNewswire/  nanoMesh™ LLC, a subsidiary of Exogenesis Corporation, announced today that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance. Exogenesis previously announced on January 26th, 2021, completion of production validation and sterilization validation as an immediate prelude to commercialization of nanoMesh™. The company anticipates first-in-man deployment of nanoMesh™ during the 2nd quarter of 2021, followed immediately thereafter by national distribution. nanoMesh™ is an innovative soft tissue repair implant. nanoMesh™ possesses a unique nanometer-level surf

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