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Feb 17, 2017

Philips receives FDA 510(k) clearance to market the next-generation of IntelliVue Guardian Solution to aid clinicians in identifying potential signs of early patient deterioration

The IntelliVue Guardian Solution includes connectivity with the Philips Wearable Biosensor

Amsterdam, the Netherlands - Royal Philips (NYSE: PHG,AEX: PHIA), a global leader in health technology,  today announced the latest release of the IntelliVue Guardian Solution has received 510(k) clearance from the Food and Drug Administration (FDA) for use with the Philips Wearable Biosensor.   Designed to aid clinicians in the early detection of subtle signs of patient deterioration in the general care ward, the Philips IntelliVue Solution includes connectivity with the Philips Wearable Biosensor, a medical-grade, self-adhesive, single patient-use wireless device worn discreetly on the chest. 


The Wearable Biosensor automatically and continuously measures heart rate, respiratory rate and posture, and detects falls. This data is then transmitted to the IntelliVue Guardian Solution, which analyzes the combined trends of the measurements over a configurable period of time and notifies the appropriate clinician when preset limits are exceeded. The combined solution provides clinicians with peace of mind that their patients are being monitored frequently for signs of deterioration between spot checks while they are attending to other tasks, while also providing patients with freedom of mobility. 


Change in respiratory rate is one of the most important predictors of patient deterioration, and most adverse events in the general care ward are preceded by this warning sign six to eight hours prior to an event1. The IntelliVue Guardian Solution is designed to help improve patient care, financial outcomes and clinician workflow by facilitating early intervention with Early Warning Score (EWS) calculations. Having automated tools that provide a comprehensive view into a patient’s condition helps enhance workflow efficiencies, simplify the medical documentation process and better utilize limited staff resources. The solution expands on Philips’ continuing commitment and leadership in patient monitoring across the care continuum.


“Under IDE abbreviated requirements, Augusta University and AU Health are piloting the solution at the site to investigate this innovative combination of the IntelliVue Guardian Software in tandem with the Philips Wearable Biosensor,” said Dr. Kevin Dellsperger, M.D., Ph.D., Vice President and Chief Medical Officer and Associate Dean for Clinical Affairs at Augusta University Health.


“This latest version of the IntelliVue Guardian Solution helps transform the way care is being delivered through the early detection of patient deterioration, particularly when paired with a solution like the Wearable Biosensor,” said Carla Kriwet, Chief Business Leader, Connected Care and Health Informatics, Philips. “We are now able to bring the clinical benefits of predictive trend analytics to important areas in the hospital, such as the general care departments, and eventually into the home.”


The latest release of the solution has been available in countries requiring the CE Mark since October 2016 and will be widely available in the U.S. in early 2017. 


Philips will showcase its connected health, integrated technology, software, solutions and services at booth #2105 at the Healthcare Information and Management Systems Society (HIMSS) 2017 Annual Meeting and Exhibition, February 19 - 23, at the Orange County Convention Center in Orlando, FL. Philips executives and customers will also be participating in the following sessions:

  • “Patient Safety in a Connected World: A Fireside Chat with Carla Kriwet” – Carla Kriwet, Chief Business Leader, Connected Care and Health Informatics, will be participating in a fireside chat with veteran technology journalist  and the CEO and Founder of Techonomy, David Kirkpatrick, on Tuesday, February 21 at 11 a.m at Philips booth #2105. 
  • “Improving Patient Outcomes and Health Economics through Connected Health Innovation” – Dr. Kevin Dellsperger of Augusta University Health and Jeroen Tas, Chief Innovation and Strategy Officer for Philips, will be presenting on the Wearable Biosensor pilot in their Views From the Top session on Tuesday, February 21 at 11:30 a.m. at Chapin Theater.


For updates, follow @PhilipsLiveFrom or visit for more information on Philips’ presence at #HIMSS17.


1 Devita MA, Bellomo R, Hillman K, et al. Findings of the first consensus conference on medical emergency teams. Crit Care Med 2006;34:2463–78.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips' health technology portfolio generated 2016 sales of EUR 17.4 billion and employs approximately 70,000 employees with sales and services in more than 100 countries. News about Philips can be found at

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Kathy O'Reilly

Kathy O'Reilly

Philips Global Press Office

Tel.: +1 978-221-8919

Joost Maltha

Joost Maltha

Philips Global Press Office

Tel: +31 6 10 55 8116

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