nusurface meniscus implant fda approval

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 03/16/17. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. endstream endobj 792 0 obj <>stream A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. First polymer-based meniscus implant granted expedited review by FDA 02/22/17. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. app.2). Although the clinical use of the NUsurface Meniscus Implant started in Europe and Israel in 2008 and 2011, respectively, evidence-based clinical data remains largely absent. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov hD The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. As I wrote in . FDA Grants Breakthrough Device Designation for NUsurface Implant Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. FDA Grants Breakthrough Designation to 'Artificial Meniscus All rights reserved. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation, Medtech in a Minute: A Shocking M&A Rumor, and More, Medtech in a Minute: Medtronic Layoffs, and More. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts.

Star Grass Root Buyers, Houses For Rent Under $500, Articles N