FDA Approval

Omnia Medical’s ‘Boxcar’ has been granted FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions. Read more


Ireland-based medical device manufacturer Medtronic has received U.S. Food and Drug Administration (FDA) approval for the company’s new Valiant Navion thoracic stent graft system. Read more


The Eluvia Drug-Eluting Vascular Stent

Boston Scientific

Boston Scientific’s recent FDA approval for the Eluvia Stent System may disrupt Cook Medical’s position in the US peripheral stents market, with Cook expected to face stronger competition trying to maintain a larger share of the market in the future. Read more

North America