Smith & Nephew get FDA approval for bone-healing ultrasound device

By Elaine Rigoli

Tampa, Fla., July 18 - Smith & Nephew has received Food and Drug Administration approval for its Exogen 4000+ bone-healing system, a low-intensity pulsed ultrasound device that is externally applied 20 minutes a day over the site of a broken bone.

The company said this is the only bone stimulator that uses ultrasound technology approved to treat fractures that have failed to heal as well as to heal certain fresh fractures.

The Exogen 4000+ is medically proven to promote the body's natural healing process, speeding the repair of a broken bone. The system is also clinically proven to speed up the healing of certain new fractures by 38% and effectively healing 86% of hard-to-heal bone fractures, the company said in a news release.

The system will launch in domestic and international markets this fall and will replace the Exogen 2000+.

Smith & Nephew is a global medical technology business based in Memphis, Tenn.

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