FDA Neuro Panel Will Review Cyberonics, Confluent Postmarket Data
FDA's Neurological Devices Panel will consider post-approval study data for Cyberonics' implantable VNS Therapy for treatment-resistant depression and for Tyco/Confluent Surgical's DuraSeal cranial surgery sealant system Jan. 26, FDA announced Dec. 22
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During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.