Philips N.V. (PHG) Announces Receipt of FDA Marketing Clearance for Lumify
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Royal Philips (NYSE: PHG) 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.
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