Technology | Magnetic Resonance Imaging (MRI) | June 07, 2018

Philips Receives FDA 510(k) for Ingenia Elition MR System

Philips also reports first installation of system that performs MRI exams up to 50 percent faster

Philips Receives FDA 510(k) for Ingenia Elition MR System

June 7, 2018 — Philips announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ingenia Elition 3.0T magnetic resonance imaging (MRI) solution and two clinical applications, Philips Compressed Sense and 3D APT. This integrated suite of innovations enables clinicians to perform exams up to 50 percent faster [1], increase diagnostic confidence and improve the patient experience.

The first commercial installation of the Philips Ingenia Elition in the U.S. has recently been completed at Hennepin Healthcare, a comprehensive healthcare system in Minneapolis.

In today’s healthcare landscape – where reimbursements are becoming value-based and chronic conditions lead to more MR procedures and longer waiting times – there is an ever-increasing pressure on the radiology department. Philips is responding to these challenges through the development of new systems and clinical applications that improve image quality and the patient and staff experience, as well as operational efficiency.

“To deliver fast, consistent and accurate diagnoses, our staff need to be supported with technology that gives them the ability to provide the best patient care, in an efficient and cost-effective way,” said Chip Truwit, M.D., chair, radiology, Hennepin Healthcare. “Philips’ Ingenia Elition plays a critical role in elevating the standard of care for our patients in imaging and in improving overall operations in our new imaging center.”

Philips Ingenia Elition and the entire digital MR portfolio empower a faster, smarter and simpler path to diagnosis – providing patients and radiologists with the following benefits:

  • Speed of care – By uniting Philips’ dStream digital broadband technology with Compressed Sense across its new digital MR portfolio, radiologists can benefit from up to 50 percent [1] faster exam times, increasing throughput and workflow efficiency and resulting in more time with patients. Additionally, SmartExam analytics enable automatic planning, scanning and processing of exams that help improve the entire MR workflow, from image acquisition to reading preference.
  • Confident diagnosis – 3D APT is a contrast-free brain MR imaging solution that addresses the need for more confident diagnosis in neuro-oncology. By differentiating low-grade and high-grade gliomas, radiologists have the ability to better understand a tumor’s progression and determine the effect of treatment [3] [4].
  • Improved patient experience – The MR Elition combined with Philips Ambient Experience and in-bore Connect solution offers an immersive audio-visual experience that may help calm patients, improving the quality of service for the patient. Herlev Gentofte University Hospital in Denmark managed to reduce the number of rescans by up to 70 percent [5] using the Ambient Experience in-bore Connect solution with its Ingenia 3.0T MR, allowing radiologists to handle more patients per day [6]. In addition to Ambient Experience, Philips’ VitalEye brings a unique patient sensing approach, enabling an intelligent respiratory signal – allowing routine exam set-up time to occur in less than a minute [7] – as a part of Philips VitalScreen technology that allows workflow integration and patient setup.

In addition to receiving U.S. FDA approval the Ingenia Elition 3.0T is also available for sale in Europe.

For more information: www.usa.philips.com/healthcare

 

References

[1] Using Compressed SENSE technology and compared to Philips exams without Compressed SENSE

[2] SmartExam is not available to patients with MR Conditional implants

[3] Togao et al. (2014) Neuro-Oncology

[4] Park KJ et al. (2016) European Radiology

[5] Results from case studies are not predictive of results in other cases. Results in other cases may vary

[6] Compared to the average of the other five Philips MR scanners without Ambient Experience and In-bore Connect. Results from case studies are not predictive of results in other studies. Results in other cases may vary

[7] Based on in-house testing

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