Neuraceq Automated Synthesizer Synthera® (Neuraceq Synthera®) Received Shonin Approval in Japan
Piramal Imaging S.A. today announced that it has received Shonin (medical device) approval from the Ministry of Health, Labor and Welfare (MHLW) of Japan for Neuraceq Automated Synthesizer Synthera® (Neuraceq Synthera®). The approval, obtained through Piramal Imaging's service partner, SCETI K.K., Tokyo, enables Japanese hospitals and imaging centers access to the equipment needed for on-site manufacturing of the β-amyloid imaging agent florbetaben 18F, which is approved in the EU, U.S. and South Korea under the brand name Neuraceq™.
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Source: Piramal Enterprises Ltd.