Philips receives FDA 510(k) clearance for Lumify’s S4-1 transducer

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Royal Philips has received 510(k) clearance from the U.S. Food and Drug Administration to market its S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer offers advanced sensitivity and high-resolution 2D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess patients like never before.

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.