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Exogen (US) files premarket approval (PMA) supplement for SAFHS 2000:

This article was originally published in Clinica

Executive Summary

Exogen (US) has filed a PMA supplement with the US FDA for the SAFHS 2000, a second-generation model of its Sonic Accelerated Fracture Healing System. The original device, which is being introduced into Europe, will be marketed in Japan by Teijin which will also develop Exogen's mechanical stress technology. The latter device is in a pilot US clinical trial in post-menopausal women to reduce related bone density decline.

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