Siemens' shock wave therapy "approvable" in US:
This article was originally published in Clinica
Executive Summary
Siemens Medical Solutions' SONOCUR extracorporeal shock wave therapy has moved closer to the US market after the firm received an approvable letter for the system from the FDA. The SONOCUR Basic system is intended to treat patients with lateral epicondylitis, or tennis elbow. It may have potential for use in patients who have previously failed other conventional therapies, said the Iselin, New Jersey firm. Siemens' premarket approval application is supported by data from a multicentre, 114-patient US trial.