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Home » Fibralign wins CE mark for BioBridge tissue repair device

Fibralign wins CE mark for BioBridge tissue repair device

September 15, 2020 By Sean Whooley

FibralignStanford spin-out Fibralign announced that it received CE Mark approval in Europe for its BioBridge collagen matrix.

Union City, Calif.-based Fibralign’s BioBridge has been designated as a Class III device with an indication for use in supporting lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema, according to a news release.

Made of highly purified collagen, BioBridge is a sterile, biocompatible and biodegradable surgical mesh created through Fibralign’s Nanoweave 3D scaffolding technology. It is already cleared by the FDA or use in the U.S. as a surgical mesh for reinforcing and repairing soft tissue, but it has not been approved in the states for treating lymphedema.

Fibralign additionally received an updated ISO 13485:2016 certification of its quality management system, it said in the release, demonstrating its capabilities in meeting the global International Standards Organization’s requirements for medical devices.

Filed Under: Regenerative Medicine, Regulatory/Compliance Tagged With: CE Mark, Fibralign

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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