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The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.
In this final part of a three-part series on the “Future of Surgery” we highlight perspectives of a highly skilled orthopedic robotic surgeon on where we are today in robotic surgery and where we are going, introduce innovative surgical robotics companies, and discuss medtechs’ rising role in robotic surgery.
Pharma sells the rights to Germany’s Cheplapharm, which obtained EU/Russia rights in October. Cerecor will acquire Aevi Genomics for $16.1m plus contingent value rights.
Puma Biotech has proven to be the cat with nine lives after its HER2+ breast cancer treatment neratinib received a u-turn from CHMP, granting it a positive trend vote. But even if final marketing approval is granted this year, European prospects don’t necessarily follow.
- Specialty Pharmaceuticals