Smith & Nephew Halts Sales Of Renasys Negative Pressure Wound Therapy
This article was originally published in The Gray Sheet
Executive Summary
FDA instructed to the company to obtain new clearances for design modifications already made to Renasys. The company says 510(k)s for these changes are pending.
You may also be interested in...
Orthopedics Earnings Roundup
Financial earnings reports from Smith & Nephew, Wright Medical, Zimmer, Stryker and Orthofix.
Acquisitions, New Technologies Reshaping Advanced Wound Care
Acquisitions and innovation are rapidly changing the dynamics in the global advanced wound care market, a high need, high growth market estimated at $5.4 billion in 2013. With the number of chronic wounds in major countries estimated at a whopping 26.7 million, the global advanced wound care market is projected to grow at a brisk 6% CAGR, reaching $7.3 billion by 2018.
Smith & Nephew Warning Letter Details Uncleared Product Modifications
A warning letter posted by FDA July 8 provides more details behind Smith & Nephew’s recent announcement that it was temporarily halting sales of its Renasys line of negative pressure wound therapy devices.