Philips receives FDA 510(k) clearance for Lumify’s S4-1 transducer bringing new capabilities, including cardiac imaging, to this smart-device ultrasound

October 14, 2016

Lumify can now be marketed for ambulatory and home use by healthcare professionals

 

AMSTERDAM, the Netherlands and LAS VEGAS, Nev.Royal Philips (NYSE: PHG AEX: PHIA) today announced at The American College of Emergency Physicians’ (ACEP) annual meeting that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its innovative S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer now offers advanced sensitivity and exceptional high-resolution 2D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess their patients like never before.

 

Introduced in 2015, Lumify, the Philips smart device powered ultrasound solution, helps healthcare professionals make fast, informed decisions.  Now Lumify is the first Philips ultrasound device for ambulatory use, and with the S4-1 transducer, its clinical applications are expanded to include a full offering of in-demand cardiac, abdominal including lung, OB/GYN, and FAST exam pre-sets. With Lumify’s full suite of point-of-care transducers, physicians in emergency care situations can take advantage of every crucial moment without the time and mobility restrictions of locating an ultrasound cart, which is often in use and/or in another department.

 

“Lumify is a game-changing innovation,” said Dr. John Bailitz, emergency ultrasound physician and leader with ACEP and the Social Media and Critical Care (SMACC) organization. “The affordability, flexibility and versatility of Lumify make it appealing to those working in emergency settings, and now with the S4-1 cardiac probe and FAST exam pre-sets, we can conduct critical exams at the point-of-care, resulting in more efficient triage of patients.”

 

The Lumify app and all three transducers (L12-4, C5-2, and S4-1) completed rigorous environmental and durability testing to ensure reliability for emergency, critical care, and ambulance use. The S4-1 transducer and cable weighs 152 grams and is smaller than a smartphone, adding to its versatility and mobility. Beyond integrating with everyday technology, such as off-the-shelf, compatible smart devices, Lumify also uses cloud-enabled technology to connect with PACS, shared networks and system directories. Additionally, data will be accessible on the Philips HealthSuite Digital Platform, an open and secure, cloud-based IT infrastructure, allowing clinicians and health systems access to powerful data and analytics to help improve patient care.

 

“Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands of more professionals to serve more patients in more locations,” said Randy Hamlin, VP and Point-of-Care Business Leader for Philips Ultrasound. “With the S4-1 transducer and clinical pre-sets, Lumify is further extending the reach of ultrasound by delivering exceptional image quality, now for routine cardiac exams, and creating better connections between clinicians and their patients.”

 

In addition to the innovative subscription pricing model, Lumify is also now available through a one-time purchase transaction.  For more information on Lumify and the full suite of Philips advanced ultrasound solutions, visit www.lumify.philips.com. Lumify will also be showcased at the RSNA 2016 annual meeting in Chicago, Ill., Nov. 27 – Dec. 1. Follow @PhilipsLiveFrom and visit www.philips.com/rsna for updates on Philips integrated technology, software solutions and services driving first time right diagnosis and treatment in radiology.

For further information, please contact:

Sarah Haeger

Philips Ultrasound

Mobile: +1 206-920-8726

Email: Sarah.Haeger@philips.com

Twitter: @sarahhaeger

 

Kathy O'Reilly 

Philips Group Communications
Tel: +1 978-659-2638 

Mobile: +1 978-221-8919

Email: Kathy.Oreilly@Philips.com

Twitter: @kathyoreilly

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. The company, headquartered in the Netherlands, 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 2015 sales of EUR 16.8 billion and employs approximately 69,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.