Royal Philips has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device.
The pocket-sized and lightweight S4-1 transducer provides advanced sensitivity and high-resolution 2D image quality.
It also features new exam pre-sets that will allow clinicians to quickly triage and assess their patients/
The S4-1 transducer enables Lumify to expand its clinical applications to include a full offering of in-demand cardiac and abdominal comprising of lung, OB/GYN, and FAST exam pre-sets.
Lumify app, along with L12-4, C5-2, and S4-1 transducers, can be used in emergency, critical care and ambulatory applications.
Lumify also uses cloud-enabled technology to connect with PACS, shared networks and system directories.
In addition, the data is available on Philips’ HealthSuite digital platform, helping clinicians and health systems to access data and analytics to improve patient care.
Philips will exhibit the Lumify at the RSNA 2016 annual meeting in Chicago, US, which will be held from 27 November to 1 December.
Philips ultrasound point-of-care business leader and vice president 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.
“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.”
Image: Royal Philips has secured FDA approval for S4-1 cardiac transducer to incorporate with Lumify diagnostic ultrasound solution. Photo: courtesy of Koninklijke Philips.