A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
Three new novel device or indication approvals were added to Medtech Insight's Approval's Tracker last week, including two from the US and one from China.
Cook Group Inc. gained de novo go-ahead May 7 for its Hemospray hemostatic powder for endoscopic hemostasis, and Teva Pharmaceutical Industries Ltd. nabbed a PMA approval May 8...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
