Global Device Approvals, Weekly Snapshot: FoundationOne CDx In Japan
Executive Summary
A snapshot of global medical device approvals captured during the past two weeks by Medtech Insight's Approvals Tracker. Among the noteworthy approvals in the closing days of 2018, Roche/Foundation Medicine captured Japanese approval for its comprehensive companion diagnostic.
You may also be interested in...
2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott
Reported sales and earnings from the publicly traded cardiovascular device companies in 2018 were generally strong, led by transcatheter aortic valve replacement devices, but some sectors of the industry, especially ventricular assist devices and peripheral drug-coated balloons, face significant challenges. Here's a recap of results from the cardio device companies that have reported so far, with a focus on Medtronic, Edwards, and Abbott.
As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?
Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.
First Expedited NGS Test Breaks Through FDA Review
FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.