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Home » Philips wins FDA 510(k) for IntelliSpace Portal 9 informatics platform

Philips wins FDA 510(k) for IntelliSpace Portal 9 informatics platform

June 27, 2017 By Fink Densford

Philips

Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its IntelliSpace Portal 9.0 clinical informatics platform and associated applications for radiology.

The newly cleared platform now includes additional applications for longitudinal brain imaging and multi-modality tumor tracking, as well as lung nodule assessment, the company said.

“Analytics applications optimized for clinical decision support and longitudinal and quantified patient tracking are becoming increasingly important to radiologists. They can help visualize and quantify very subtle manifestations of disease and differences over time that may not be seen with the naked eye. IntelliSpace Portal 9.0 integrates into our existing workflow and adds greatly to our patient care,” development partner Mark van Buchem of the Leiden University Medical Center said in a prepared statement.

The system has been available outside the US since last November, and will be launched in the US this month, Philips said.

“IntelliSpace Portal shows how we continuously innovate to help clinicians achieve first-time-right diagnoses, track disease development, and improve patient care. Together with clinical partners we develop solutions that help add depth and insight to a physician’s diagnosis. Our newest clinical informatics innovations can now be used to help streamline care for more and even the most complex patients,” healthcare informatics biz lead Yair Briman said in a press release.

Last week Philis said it agreed to acquire Electrical Geodesics for $36.7 million (GBP £29 million). The company said that EGI’s portfolio of EEG hardware, software and acquisition sensors would work to complement its existing imaging tech and advanced informatics portfolio for neurological applications.

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance, Software / IT Tagged With: Philips

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