AMSTERDAM (dpa-AFX) - Royal Philips (PHG) announced that it has received 510(k) clearance from the US Food and Drug Administration or FDA to market its AlluraClarity live image guidance system in the US.
Philips said that its AlluraClarity system with its powerful 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. To reflect the cost pressures that modern hospitals and health systems face, ClarityIQ technology will also be available as an upgrade for the majority of Philips' installed base of monoplane and biplane interventional X-ray systems.
According to the company, AlluraClarity's low X-ray dose settings are a radical new development in the healthcare industry that will help clinicians to better manage their patients' and their own exposure to X-ray radiation. The company said that the achievement was the result of a multi-year development program that formed part of Philips' continuous investment in healthcare R&D, totaling 803 million euros in 2012.
The company noted that its AlluraClarity was commercially introduced outside the US in mid-2012, and since then more than 200 systems have been ordered.
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