FDA Clears New Philips Imaging System

The healthcare unit of Royal Philips has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AlluraClarity live image guidance system.

Philips’ AlluraClarity uses the company’s ClarityIQ technology for what the company terms “high-quality imaging” for a  range of clinical procedures, and, according to the company, “for achieving excellent visibility at low X-ray dose levels for patients of all sizes.” To reflect the cost pressures that modern hospitals and health systems face, ClarityIQ technology also will be available as an upgrade for the majority of Philips’ installed base of monoplane and biplane interventional X-ray systems, the company said.

“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,” said Dr. Marco van Strijen, interventional radiologist at the St. Antonius Hospital Utrecht/Nieuwegein, the Netherlands. “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.”

“The transition from highly invasive surgical procedures to minimally invasive image-guided therapies, with all their intrinsic patient benefits, is a transformation in the delivery of healthcare that is rapidly accelerating around the globe,” said Gene Saragnese, CEO, Imaging Systems at Philips Healthcare. “It is an area where technology innovation and procedure innovation go hand in hand. AlluraClarity is a perfect example of how Philips’ close collaboration with clinical partners has combined these two areas of innovation to facilitate more advanced treatment while at the same time managing radiation dose.”

AlluraClarity’s low-dose settings will help clinicians to better manage their patients’ and their own exposure to X-ray radiation, officials noted. This achievement is the result of a multi-year development program that formed part of Philips’ continuous investment in healthcare R&D, totaling roughly $1 billion  in 2012.

Philips’ AlluraClarity was available outside the United States in mid-2012, and since then more than 200 systems have been ordered.
Royal Philips Electronics is headquartered in the Netherlands, and is an engineering and electronics conglomerate. The healthcare division’s U.S. base is in Andover, Mass.