A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
Seven novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week, including US approval of a new formulation for a biologic-device bone graft and Japanese approval of a less-invasive surgical heart valve.
Wright Medical gained a panel-track PMA supplement approval for Augment Injectable, the injectable version of the currently available Augment graft...
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
