Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel

RAYUS Radiology Quality Institute Distinguished Nationally by Centers for Medicare & Medicaid

Quality Institute Again Earns Certification as Provider-Led Entity for Advanced Diagnostic Imaging Guidance to Clinicians.

LX1550 Multiparameter Remote Monitoring Platform Receives FDA 510 (k) Approval: Reports LifeSignals

Further validation of ability to deliver continuous remote patient vital signs monitoring within both hospital and home settings.

U.S. News & World Report Names Tampa General Hospital as Best in Tampa Bay

This is the sixth consecutive year that Tampa General has been named by U.S. News & World Report as Tampa Bay's top hospital.

October 12, 2020

Agili-C implant has received FDA Breakthrough Device Designation. CartiHeal announced the news today. FDA’s Breakthrough Device Program is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients receive more timely access to these medical devices by expediting their development, assessment and review by FDA.

CartiHeal is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C™ implant superiority over the current surgical standard of care – microfracture and debridement. In total 251 Subjects were enrolled in 26 sites in the US, Europe and Israel. The study includes Subjects with both mild to moderate osteoarthritis and focal defects, without arthritic changes. Final study results are expected next year.

“We are extremely pleased that FDA granted the Agili-C implant Breakthrough Device Designation,” said Nir Altschuler, CartiHeal’s Founder & CEO. “We look forward to working closely with FDA to expedite Agili-C’s review process, once the final IDE study results will be available, in order to provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options.”

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.