FDA Approves Investigational Device Exemption for Agili-C Implant

CartiHeal received FDA approval of its Investigational Device Exemption application submitted for the Agili-C™ implant, towards a Premarket Approval application.

The 2-year U.S./ex-U.S. pivotal study will involve a minimum of 250 patients, and seeks to show superiority of Agili-C vs. microfracture and debridement in the treatment of...

document icon

You are out of free articles for this month

Subscribe as a Guest for $0 and unlock a total of 5 articles per month.

You are out of five articles for this month

Subscribe as an Executive Member for access to unlimited articles, THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.


Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

Contact Us