US Approvals Analysis: Strong Month For IVD De Novos In February
FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.
You may also be interested in...
US FDA Device-approval volumes were strong during the first half of 2017 for all review pathways. Medtronic and Siemens have so far captured the most 510(k) clearances, with Cook close behind. That and more from Medtech Insight's Approvals Tracker.
Two de novo go-aheads granted by FDA last month sent non-implantable neurostimulation devices to market, one for headaches and the other for tear production. Overall, the agency granted four de novos in April, continuing a strong trend this year for that marketing pathway, according to Medtech Insight's Approvals Tracker.
This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.