The Medicare hospital inpatient final rule gives new technology add-on payments to just two devices, Ellipse Technologies's Magec spinal bracing and distraction system, and Gore's Excluder iliac branch endoprosthesis. Two other requests were turned down, and another device was not FDA-approved in time.
Only two devices that applied for new-technology bonus US Medicare payments for fiscal year 2017 made the cut in the latest Medicare hospital inpatient final rule.
Of the five devices up for new technology add-on payments in the Centers for Medicare and Medicaid Services' April proposed...
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
