Smith & Nephew Orthopaedics of Memphis, TN, announced last week that it has received premarket approval from the FDA to market its Exogen 2000, a noninvasive ultrasound fracture therapy, for the treatment of established nonunion bone fractures.The
Smith & Nephew Orthopaedics of Memphis, TN, announced last week that it has received premarket approval from the FDA to market its Exogen 2000, a noninvasive ultrasound fracture therapy, for the treatment of established nonunion bone fractures.
The FDA approved the Exogen device in 1994 as a treatment for the acceleration of fresh fracture healing. With this PMA, Exogen becomes the only bone stimulation treatment available for both fresh and nonunion fractures. Currently, the therapy has been prescribed for more than 18,000 patients in the U.S. by more than 7000 physicians.
A nonunion is considered to be established when a fracture is at least nine months old and has shown no progression of healing for at least three months. According to Smith & Nephew, their clinical studies for the PMA resulted in an 86% healed rate for nonunion fractures that failed to heal after prior orthopedic treatment. Exogens proprietary ultrasound and mechanical stress technologies are based on the principle that bone growth is stimulated by mechanical force.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Chest CT for Post-COVID-19 Abnormalities: Nine Takeaways from a Multi-Society Consensus Statement
July 22nd 2025Developed by 21 thoracic radiologists, the new international consensus statement addresses appropriate indications, scan acquisition and keys to reporting for the use of chest CT imaging in evaluating for residual lung abnormalities from COVID-19.
FDA Clears New Radiography/Fluoroscopy Systems from Siemens Healthineers
July 21st 2025Offering ergonomic controls and AI-enabled features, the remote-controlled Luminos Q.namix R system and the Luminos Q.namix T platform with tableside control reportedly facilitate workflow efficiencies for complex radiography and fluoroscopy examinations.