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Fibralign Announces Strategic Partnership with Terumo

Fibralign Announces Strategic Partnership with Terumo

Exclusive agreement for Terumo to market and distribute Fibralign’s BioBridge in Japan June 02, 2020 06:00 AM Eastern Daylight Time UNION CITY, Calif.--(BUSINESS WIRE)--Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced...

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign announced today that it has been awarded a Small Business Innovation Research (SBIR) Sequential Phase II (Phase IIS) from the Department of Defense (DoD) Defense Health Program (DHP). This two-year grant provides $996,609 in funding to continue advancing...

Fibralign receives ISO 13485:2016 upgrade certification

Fibralign receives ISO 13485:2016 upgrade certification

Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company's management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management...

Fibralign receives ISO 13485:2012 Certification

Fibralign receives ISO 13485:2012 Certification

Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it's management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012. The scope of the certification is for the design, development,...

Fibralign wins BSK biotech startup competition!

Fibralign wins BSK biotech startup competition!

Wins $30,000 first place prize among >150 amazing startups in CA event held April 7th at Stanford Medical school. Sponsored by BioSciKin, a Chinese biotech venture focused on precision medicine. See full article at http://califesciences.org/bioscikin-1/. Fibralign...

BioBridge® Collagen Matrix receives 510(k) clearance

BioBridge® Collagen Matrix receives 510(k) clearance

Fibralign's first product, the BioBridge® Collagen Matrix has received 510(k) clearance from the FDA on January 07, 2016 for use in soft tissue support/repair (K151083). Click to view. BioBridge is a sterile thread-like surgical mesh designed for use in surgery to...