The FDA and the Centers for Medicare & Medicaid Services (CMS) will conduct a parallel review of Symplicity, a renal denervation system for treatment-resistant hypertension. The review allows CMS to begin consideration for national coverage determination while the FDA completes its review of the safety and efficacy.

Boston Scientific, sponsor of the PREVAIL study set to be featured March 9 as a late-breaking clinical trials at the American College of Cardiology (ACC) scientific sessions in San Francisco, announced that the presentation will focus on acute procedural safety results and not the complete results.

Philips has received 510(k) clearance from the FDA to market its EchoNavigator live image-guidance tool. 

The FDA has issued a second complete response letter on a supplemental New Drug Application for rivaroxaban for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome.

A bedside device that can calibrate subtle eye and head movements may be key to correctly diagnosing strokes in patients who present with dizziness, nausea, nystagmus, unsteady gait and head movement intolerance.

Combining research-derived data, practice guidance and common clinical experience, the American College of Cardiology Foundation, the Heart Rhythm Society and other specialty societies released appropriate use criteria (AUC) for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy.

WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.

One-quarter of patients with occlusive arterial disease who received extended release niacin in addition to statins discontinued treatment, primarily due to adverse reactions. Results, published online Feb. 27 in European Heart Journal , showed a four-fold excess risk of myopathy in patients taking the combination therapy, with patients in China facing even higher risks.