Terumo Aneurysm Device Gets FDA Panel Date
US FDA's Neurological Device Panel is set to meet Sept. 27 to weigh the merits of a PMA submitted for the WEB embolization device for treating aneurysms.
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Terumo will pay up to $380m for privately-held Sequent Medical to and improve its presence in the US neurovascular device market with Sequent’s WEB embolization system for treatment of wide-neck bifurcation intracranial aneurysms, the Japanese medtech giant announced on June 16.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him?