Japan, Taiwan grant Volpara regulatory clearance

By AuntMinnie.com staff writers

November 21, 2017 -- Breast imaging software developer Volpara Solutions has received regulatory clearances for its suite of quantitative breast imaging software in Japan and Taiwan.

In Japan, the full VolparaEnterprise suite received regulatory approval as a class II medical device. In Taiwan, VolparaDensity and VolparaDose received regulatory clearance as a class II medical device from the Taiwan Food and Drug Administration (TFDA).

VolparaEnterprise software is not classified as a medical device in Taiwan and does not require regulatory approval, according to the firm.

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