What To Know
- Fibralign notes that BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema.
- This novel medical device is commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue.
September 14, 2020
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge® Collagen Matrix.
Fibralign notes that BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema.
CE mark is a certification symbol in Europe that signals conformity to patient safety and device performance standards applicable in the region. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive, which now allows Fibralign to market BioBridge across the European Union and other CE mark countries.
Fibralign also received an updated ISO 13485:2016 certification of its quality management system. This certification demonstrates the company’s focus on quality and its ability to meet the global International Standards Organization (ISO) requirements and standards for the design, manufacture, and distribution of medical devices.
BioBridge is a sterile, biocompatible and biodegradable surgical mesh made of highly purified collagen and is created with Fibralign’s patented Nanoweave® 3D scaffolding technology. This novel medical device is commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema. BioBridge has not been approved in the US by the FDA for treating lymphedema.