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November 26, 2014

FDA grants 510(k) clearance for Philips’ IQon Spectral CT

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Netherlands-based Royal Philips' IQon Spectral CT, which is said to be a new approach to spectral imaging.

Royal

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Netherlands-based Royal Philips’ IQon Spectral CT, which is said to be a new approach to spectral imaging.

The company said that this technology adds a new dimension to computed tomography (CT) imaging, delivering anatomical information and offering the ability to characterise structures based on their material content within a single scan.

The improved image quality may help improve confidence in diagnoses and deliver operational efficiency.

The new CT system has been developed in collaboration with clinicians to solve some of their most immediate challenges, including workflow and image management issues.

The new system’s technology can discriminate between X-ray photons of multiple high and low energies.

Clinicians can access the conventional greyscale anatomical images, along with the spectral information within the same scan, through the Spectral CT scan.

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Philips Healthcare Imaging Systems CEO Gene Saragnese said: "The IQon Spectral CT represents our commitment to leading a new, higher standard for medical imaging that is driven by clinical insights and focused on the patient experience.

"Delivering an additional level of spectral information without impacting clinician workflow is vital for confident diagnoses that can significantly add value to help improve patient care."

"The improved image quality may help improve confidence in diagnoses and deliver operational efficiency."

The new CT system, which is currently available for sale in around 36 countries, will be exhibited at the upcoming Radiological Society of North America Annual Meeting (RSNA) that will be held from 30 November to 5 December in Chicago.

Israeli Radiology Society president and Hadassah Hebrew University Medical Center chairman of the Department of Radiology Jacob Sosna, who collaborated with Philips on the development of the product, said: "Spectral imaging has the potential to change the way clinicians practice radiology in the future.

"A recent study with Philips IQon Spectral CT revealed enhanced diagnosis in up to 70% of cases.

"Using the prospective approach, we would only have access to spectral information in 20% or 25%, at maximum."

CT imaging is mostly used in the diagnosis of many different diseases and injuries, due to its accessibility, speed and accuracy.


Image: Philips receives FDA 510(k) clearance for IQon Spectral CT. Photo: courtesy of Royal Philips / PRNewswire.

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