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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 Centers for Medicare and Medicaid Services (CMS) will draft a proposed rule that would create an expedited Medicare coverage pathway for medical devices, according to a CMS op-ed piece published in JAMA Internal Medicine. Read More
Quality management in the supply chain relies on traceability of and accountability for device components and finished products anywhere in the world, according to one supply chain management authority. 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
DNA sequencing giant Illumina is teaming up with AstraZeneca to seek out potential new drug targets using Illumina’s genomic analysis artificial intelligence (AI) technology. Read More