Philips’ CT and PET/CT cleared for low-dose lung screening by FDA

Philips’ CT and PET/CT cleared for low-dose lung screening by FDA

by Christina Hwang, Contributing Reporter | April 27, 2016
CT Medical Devices Risk Management X-Ray
Personalized management,
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Philips IQon Spectral CT
Philips CT and PET/CT models have been approved by the FDA for low-dose CT (LDCT) lung cancer screening, so now any hospital or health care facility with one of the approved modalities can become a lung cancer screening center.

The 27 models that are qualified for CT lung cancer screening can be used for dose management and image data sharing and analytics through the Philips IntelliSpace Portal, which helps physicians with improving workflow and patient care. IntelliSpace Portal 8.0 has a new CT Lung Nodule Assessment (LNA) application designed to provide clinical decision support.

Also available, referring physicians are able to manage the CT scanning process through control center software tools that allow for digital access to patient tracking data. This will help provide insight on scheduling appointments, seeing scan results and recommending follow-up activities.

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None of the Philips CTs will need hardware or software modifications. The qualified systems in the installed base comprise a set of up to three reference low-dose CT lung cancer screening protocols, and also has "instructions for use” that cover all systems used for LDCT.

“With this clearance, Philips offers and expands the ability to support screening applications for lung cancer for any hospital or health care facility that has Philips CT or PET/CT models on site,” Mikael Strindlund, senior VP and general manager of CT, Philips told HCB News.

“This gives health care organizations of varying clinical and economic needs — from community hospitals to multi-facility health systems — the ability to establish and maintain robust lung cancer screening programs as well as provide services that may offer easier access for at-risk patients,” he said.

The American Cancer Society estimates that 224,390 new cases of lung cancer were diagnosed this year, and each year more people die from lung cancer than colon, breast, and prostate cancers combined.

“The work Philips has done to improve a provider’s screening capability not only benefits individual patients, but hospitals at each step of their Lung Cancer Screening program implementation and execution, which is often a very complicated process that includes community outreach, physician education, patient and data management, and reporting,” said Brady J. McKee, radiologist at Lahey Hospital and Medical Center, in a statement.

In August of last year, GE Healthcare became the first OEM to receive FDA clearance for a lung cancer screening option that utilizes low-dose CT. Siemens Healthcare followed in November when its SOMATOM CT for low-dose lung cancer screening was FDA approved.

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