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The FDA has pushed back once again on Supernus Pharmaceuticals’ New Drug Application (NDA) for its investigational apomorphine infusion device, designed to continuously treat motor fluctuations in Parkinson’s disease (PD). Read More
The new certification is for compliance with the EU Medical Device Regulation, which requires additional technical documentation, clinical data and postmarket surveillance. Read More
The software is not meant to be used as an active patient monitoring system but to supplement the hospital’s device monitoring, the company said. Read More