Philips has received 510(k) clearance from the FDA for its S4-1 cardiac transducer for Lumify, the company’s smart-device diagnostic ultrasound platform. Providing advanced sensitivity, high-resolution 2D image quality and new exam presets, the pocket-sized S4-1 transducer allows clinicians to quickly triage and assess their patients.
The platform—which will be on display at the Radiological Society of North America’s 2016 Annual Meeting in Chicago next month—can now be marketed for ambulatory and home use by healthcare professionals.
Enabling clinical teams to make fast, informed decisions, Lumify was introduced to the market in 2015. The first ultrasound device for ambulatory use from Philips, the S4-1 transducer’s clinical applications have expanded to include a full complement of abdominal, cardiac, Focused Assessment with Sonography for Trauma (FAST), and Ob/Gyn exam pre-sets. In emergency care situations, physicians can make the best use of their time, since they don’t need to locate an ultrasound cart, which is often either in use or located in another department.
The Lumify application and its three transducers (L12-4, C5-2, and S4-1) completed comprehensive environmental and durability testing to ensure reliability for ambulance, critical care, and emergency use. Physically smaller than a smartphone, the S4-1 transducer weighs 5.36 ounces—making it versatile and mobile. With its cloud-enabled technology, Lumify can connect with PACS’, shared networks, and system directories. Clinicians and health systems can access the solution’s data on the Philips HealthSuite Digital Platform, which is a cloud-based IT infrastructure providing data and analytics.
“Lumify is a game-changing innovation,” says John Bailitz, MD, an emergency ultrasound physician and a leader with the American College of Emergency Physicians and the Social Media and Critical Care 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 presets, we can conduct critical exams at the point of care, resulting in more efficient triage of patients.”
Randy Hamlin, vice president and point-of-care business leader for Philips Ultrasound, adds: “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. With the S4-1 transducer and clinical presets, 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.”
For more information about this technology, visit Philips.