FDA Clears Philips' AlluraClarity Interventional X-Ray System

July 3, 2013—Royal Philips Electronics (Andover, MA) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the AlluraClarity live-image guidance system in the United States. The AlluraClarity was commercially introduced outside the United States in 2012.

According to the company, the AlluraClarity system's ClarityIQ technology provides high-quality imaging for a comprehensive range of clinical procedures, achieving excellent visibility at low x-ray dose levels for patients of all sizes. ClarityIQ technology will also be available as an upgrade for the majority of Philips' installed base of monoplane and biplane interventional x-ray systems.

Marco van Strijen, MD, interventional radiologist at the St. Antonius Hospital Utrecht/Nieuwegein in the Netherlands, commented on the AlluraClarity in the Philips press release. Dr. van Strijen stated, “All patients treated via x-ray–guided interventions benefit from the advantage of low radiation exposure, but it is especially important when you are treating patients who have to undergo lengthy and complex procedures. We have been using Philips' AlluraClarity system for more than a year now and have really grown to appreciate the low dose settings. This technology is making a difference where it really matters.”