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FDA panel: More data needed for embolic protection device for TAVR procedures

February 23, 2017

The FDA’s Circulatory System Devices Panel said despite flaws in current data, de novo classification may be warranted for an embolic protection device for prevention of stroke during transcatheter aortic valve replacement procedures.

Panel members stated that current efficacy data, based on findings from MRI scans, are not strong enough to assess how well the device might protect against stroke. However, many said the device serves an important need and may be worth allowing on the market because it is safe and appears to prevent disastrous outcomes.

In the Journals Plus

Physical activity, 25-(OH)D jointly influence atherosclerotic CVD risk

February 23, 2017
Addressing suboptimal levels of 25-hydroxyvitamin D, combined with efforts to increase physical activity, may lower the risk for developing atherosclerotic…
Meeting News

Embolization with hydrogel coils may reduce adverse events in endovascular treatment of intracranial aneurysm

February 23, 2017
Patients with intracranial aneurysms who underwent embolization with second-generation hydrogel-coated coils were less likely to experience adverse outcomes than those…
In the Journals

BMJ: Trump’s policies risk ‘head-on collision’ with science, health care

February 23, 2017
A commentary recently published in The BMJ expressed the editors’ concerns with President Donald J. Trump’s policies, stating that the new…

CMS awards $100 million to support small practices in Quality Payment Program

February 23, 2017
The CMS is working with 11 local, experienced, community based organizations to provide immediate hands-on training and educational resources about the Quality Payment…
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