News | July 24, 2014

Philips Receives FDA 510(k) Clearance For Its Innovative Ultra Mobile VISIQ Ultrasound System

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Transducer-plus-tablet display delivers excellent image quality, making ultrasound available anytime, in a wide range of clinical environments for OB patients

Andover, MA /PRNewswire/ -- Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its innovative ultra mobile ultrasound system, VISIQ, in the U.S. VISIQ is the first Philips ultrasound system to combine the benefits of greater mobility, performance and simplicity into a single miniaturized solution, helping clinicians increase access to quality diagnostic scans for more OB patients.

This breakthrough ultrasound device can be easily transported wherever care is needed, and its quick-start technology and long battery life make it an ideal system for physician offices, hospitals and other clinical settings.

"VISIQ marks a new vision in ultrasound for Philips by allowing physicians to perform on-the-spot diagnostic scans, limiting the need for patients to go to multiple locations or schedule return visits," said Gene Saragnese, CEO, Imaging Systems, Philips Healthcare. "VISIQ is the latest example of Philips' continued commitment to create advanced innovative technology solutions to deliver better care at lower cost and to help improve patient outcomes."

VISIQ's touch-screen gesture controls are familiar to anyone who has used a smartphone or tablet. It allows users to easily capture images, take measurements and share data. In addition, VISIQ offers many of the automatic image optimization features found on Philips' premium EPIQ system, as well as built-in Wi-Fi for DICOM data transfer to hospital or cloud-based PACS.

At the heart of the VISIQ system is a smart transducer that fits comfortably into the user's hand. Drawing on more than 30 years of experience in ultrasound, Philips has taken advantage of advances in miniaturization to integrate a sophisticated broadband micro-digital beam former and powerful image acquisition module into the transducer. VISIQ targets OB and abdominal applications and lays the foundation for a future range of portable ultrasound products to meet the evolving needs of clinicians and patients.

"Portable and convenient, VISIQ is so intuitive, with remarkable, easy-to-use measurement capabilities for maternal-fetal medicine specialists or general obstetricians," said Dr. Michael Ruma, maternal-fetal medicine specialist at Perinatal Associates of New Mexico. "Instead of just listening to the baby's heartbeat, clinicians are able to see the baby in 2D and color."

VISIQ is also commercially available in China, East Africa, France, Germany and India.

For more information on VISIQ and the full suite of Philips innovative ultrasound solutions, visit: http://www.philips.com/VISIQ.

About Royal Philips:
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2013 sales of EUR 23.3 billion and employs approximately 113,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.

Forward-looking statements:
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

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Source: Royal Philips

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