FDA grants 510(k) clearance for Royal Philips’ S4-1 cardiac transducer for Lumify

16 October 2016 (Last Updated October 16th, 2016 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips to market its S4-1 cardiac transducer for its smart-device diagnostic ultrasound solution, Lumify.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips to market its S4-1 cardiac transducer for its smart-device diagnostic ultrasound solution, Lumify.

The S4-1 transducer is a pocket-sized, lightweight device which has been designed to provide advanced sensitivity and high-resolution 2D image quality, coupled with new exam pre-sets, allowing clinicians to quickly triage and examine their patients.

The S4-1 transducer and cable weighs 152 grams, it is smaller than a smartphone making it versatile and mobile.

The new device is expected to expand the clinical applications of Lumify to include a full offering of in-demand cardiac, abdominal including lung, OB/GYN, and FAST exam pre-sets.

Philips Ultrasound vice-president and point-of-care business leader Randy Hamlin said: "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.

"The full suite of point-of-care transducers will aid physicians in addressing emergency care situations avoiding the time and mobility restrictions of locating an ultrasound cart."

"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."

The full suite of point-of-care transducers will aid physicians in addressing emergency care situations avoiding the time and mobility restrictions of locating an ultrasound cart.

The Lumify application with all the three transducers (L12-4, C5-2, and S4-1) underwent environmental and durability testing to ensure reliability in case of emergency, critical care, and ambulance use.


Image: S4-1 transducer increases clinical applications of Lumify. Photo: courtesy of Royal Philips.