Tuesday, 10 December 2019

BSD seeks Taiwan FDA nod for hyperthermia system

14 May 2013 | News | By BioSpectrum Bureau

Linden Bioscience submits marketing approval application for its BSD-2000 Hyperthermia System to the Taiwan FDA

Linden Bioscience submits marketing approval application for its BSD-2000 Hyperthermia System to the Taiwan FDA

Singapore: Medical system provider, BSD Medical's Taiwan distributor Linden Bioscience has submitted its BSD-2000 marketing approval application for the BSD-2000 Hyperthermia System (BSD-2000) to the Taiwan Food and Drug Administration (TFDA). TFDA approval of the BSD-2000 could occur as early as November 2013.

"Since signing our exclusive distributor agreement with BSD, Linden has had ongoing and very productive meetings with the TFDA," stated Mr Tainang Huang, president of Linden.

"We have filed the BSD-2000 marketing application with the TFDA, and we are working closely with the TFDA to obtain an expedited approval for marketing the BSD-2000 in Taiwan. We have also met with many prominent Taiwan physicians from several hospitals, including the very influential and largest hospital system in Taiwan, Chang Gung Memorial," he said.

"As a result of our extensive efforts to introduce the BSD-2000 in Taiwan, we have been invited to present on the BSD-2000 at an international symposium on hyperthermia in Taipei, which will be held in November 2013 at Wan Fan Hospital, Taipei Medical University. We are excited about the interest expressed in the BSD-2000 in Taiwan," added Mr Huang.

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