Royal Philips has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing them to market its S4-1 cardia transducer for Lumify.
Lumify, the smart diagnostic ultrasound device, and the S4-1 transducer provide clinicians the ability to make faster decisions on care due to its transportable structure and ability to produce high-resolution 2D images in different situations. The paring of the two devices expands on the capabilities offered by the transducer to include cardiac, abdominal, lung, OB/GYN and FAST exam options.
"Lumify is a game-changing innovation," said John Bailitz, MD, emergency ultrasound physician and leader with ACEP 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 pre-sets, we can conduct critical exams at the point-of-care, resulting in more efficient triage of patients."
The S4-1 transducer is smaller than a smartphone and has passed environmental and durability testing to ensure use across multiple situations. Using cloud technology, Lumify is able to send data to networks for quicker access, as well as being uploaded to the Philips HealthSuite Digital Platform.
"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 presets, Lumify is further extending the reach of ultrasound by delivering exceptional image quality for routine cardiac exams and creating better connections between clinicians and patients."