Terumo Aneurysm Device Gets FDA Panel Date
Executive Summary
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.
You may also be interested in...
Terumo Makes Big Bet On Aneurysm Embolization With Sequent Acquisition
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.
FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks
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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
Device Week, March 8, 2019 – Scott Gottlieb Resigns
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?