CA-FIBRALIGN
14.9.2020 20:25:12 CEST | Business Wire | Press release
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. 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.
About BioBridge Collagen Matrix
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.
About Lymphedema
Lymphedema is a serious, global, progressive disease that can develop as a result of cancer treatments. Such interventions, while life-saving, can also destroy enough lymphatic function that the cancer survivor is left with a condition in the affected limb that includes painful swelling and frequent infections. Lymphedema can ultimately lead to irreversible structural changes in the tissues, which can result in severe deformity, serious reduction in function and have a profound impact on quality-of-life. Existing treatments for lymphedema are limited and not curative.
About Fibralign Corporation
Fibralign Corporation is a commercial stage healthcare company that develops and manufactures advanced therapeutic biomedical devices designed to address significant unmet medical needs by utilizing its patented Nanoweave® 3D scaffolding technology. http://www.fibralignbio.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005790/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Brightfin Launches Spend Clearly AI to Help Enterprise Tech Leaders Take Control of Growing IT and AI Costs6.5.2026 22:32:00 CEST | Press release
New AI-powered optimization app delivers real-time visibility, cost reduction, and predictive forecasting as enterprise AI spending accelerates Brightfin, a leader in AI native IT cost optimization, today announced the launch of Spend Clearly AI, an intelligent optimization app purpose-built for enterprise technology leaders navigating the dual pressures of rising IT complexity and rapidly escalating AI investment. As organizations race to deploy AI apps, models, and infrastructure, technology demands on the budget are expanding faster than ever and growing harder to track, justify, and control. The modern enterprise IT bill has become a moving target. Spend Clearly AI gives CIOs, CTOs, and IT finance teams a single, intelligent app to see exactly where every technology dollar is going, eliminate waste, and stay ahead of costs before they spiral. "Stop thinking about IT as a cost problem. The goal isn't just to spend less — the goal is to spend better," said Joel Martins, CEO of Bright
iQmetrix to Showcase Intelligent Commerce Operating System and Catalyst Innovation at DTW Ignite 20266.5.2026 19:20:00 CEST | Press release
Bronze sponsor debut includes Catalyst project innovation, live platform demo, and a unified AI‑native commerce vision iQmetrix, the Intelligent Commerce Operating System for telecom, announced today it will exhibit, speak, and compete as a bronze sponsor at DTW Ignite 2026 in Copenhagen from June 23–25. The company will deliver a live product demo in The Loft, showcase its ODA PRISM Catalyst project alongside a consortium of global operators and technology partners, and exhibit at Booth #317 throughout the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506948390/en/ The debut marks a milestone in iQmetrix’s global growth strategy and deepens its partnership with TM Forum, following its recent recognition as an ODA Component Directory Partner. The Future of Commerce Is Won at the Orchestration Layer DTW Ignite 2026’s theme, “The Future. Faster.,” captures the urgency facing communications service providers worldwid
Go Beyond the Guidebook: Why Ireland Rewards Those Who Slow Down6.5.2026 18:15:00 CEST | Press release
In a world where travel often feels rushed and driven by checklists, Ireland stands apart. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501313521/en/ Lusty Beg Island Kesh, Co. Fermanagh The destination offers something deeper, drawing visitors beyond the expected toward richer encounters with its landscapes, culture and communities. As a compact island, Ireland gives holiday makers the chance to take in much of the destination while still travelling at a relaxed, unhurried pace. It’s a chance to slow down, not to do less, but to feel more - more calm, more connection, and more of what makes travel meaningful. This approach to travel is matched by Ireland’s natural warmth and welcome, helping visitors feel at home from the moment they arrive. Take the scenic route From the rugged coastline of the Wild Atlantic Way, one of the world’s longest coastal routes, to the rolling landscapes of Ireland’s Hidden Heartlands, Irela
TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions6.5.2026 17:18:00 CEST | Press release
Built on deep tech developed by TII, TACTICA AI moves beyond dashboards to help decision-makers turn fragmented intelligence, sensor, and operational data into action Showcased during Make it in the Emirates 2026, the platform has already been validated through real-world deployments in mission-critical environments Built in Abu Dhabi, connected globally, TACTICA AI integrates partnerships with French-based Safran and Polish-based Satim TACTICA AI, an Abu Dhabi-based start-up, today introduced its multi-domain decision-support platform to a wider market during Make it in the Emirates 2026. At a time of increasing operational complexity and pressure to make faster, better-informed decisions, the platform is designed to transform fragmented intelligence, sensor, and operational data into real-time decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506006177/en/ TACTICA AI Introduces Region’s First AI Platform for Mis
FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 16:05:00 CEST | Press release
Three aircraft programs approved, with three more expected to receive approval in 2026 FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to de
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom