Taiwan Marketing Approval Granted For BSD-2000 Hyperthermia System


BSD Medical's exclusive Taiwan distributor, Linden Bioscience, has obtained Taiwan FDA marketing approval for the BSD-2000 hyperthermia system. Linden has anticipated to an initial purchase of four BSD-2000 hyperthermia systems for market introduction. BSD will ship the systems in fiscal year ending August 31 2014.

BSD-2000 delivers localised therapeutic heating by applying radiofrequency energy. The system creates a central focusing of energy that can be electronically focused to target the shape, size and location of the tumour, thus providing dynamic control of the heating delivered to the tumour region. BSD-2000 has Humanitarian Device Exemption marketing approval from the US FDA for use in conjunction with radiotherapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The system also has CE marking for the commercial sale in Europe.

Taiwan has a strong healthcare system that provides universal health insurance. According to Espicom estimates, the country's medical device market was worth US$1.88bn in 2013.

This article is tagged to:
Related sectors of this article: Medical Devices, Regulatory - Medical Devices, MIW
Geography: Taiwan, United States