[Editor's note:Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker and at Meddevicetracker.]
The US Food & Drug Administration approved one original PMA from 30 April to 6 May.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, the US FDA approved Boston Scientific’s Vici Venous iliac vein stent system and SentreHEART announced it has received a CE mark for the 50mm version of the Lariat-RS system for left atrial appendage exclusion in patients with atrial fibrillation.
[Editor's note:Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker and at Meddevicetracker.]
The US Food & Drug Administration approved one original PMA from 30 April to 6 May.
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.