Technology | Cardiovascular Ultrasound | October 14, 2016

Philips Receives FDA 510(k) Clearance for Lumify S4-1 Ultrasound Transducer

Lumify smart-device ultrasound can now be marketed for ambulatory and home use by healthcare professionals, with new capabilities including cardiac imaging

Philips, Lumify smart-device ultrasound, S4-1 cardiac transducer, RSNA 2016

October 14, 2016 — Philips announced at The American College of Emergency Physicians' (ACEP) annual meeting that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer now offers advanced sensitivity and high-resolution 2-D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess their patients.

Introduced in 2015, Lumify, the Philips smart device-powered ultrasound solution, helps healthcare professionals make fast, informed decisions. Now 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 (Focused Assessment with Sonography in Trauma) 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.

Watch a video explaining the Lumify system as part of the "Editor's Choice of the Most Innovative Imaging Technology at RSNA 2015."

"Lumify is a game-changing innovation," said John Bailitz, M.D., 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 picture archiving and communication systems (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.

In addition to the subscription pricing model, Lumify is also now available through a one-time purchase transaction. 

Lumify will also be showcased at the Radiological Society of North America (RSNA) 2016 annual meeting, Nov. 27-Dec. 3 in Chicago.

For more information: www.philips.com


Related Content

News | Cardiac Imaging

March 28, 2026 — When Ashley Perlow felt a sharp pain shoot across her chest and into both wrists, she didn't think it ...

Home April 01, 2026
Home
News | Cardiac Imaging

March 18, 2026 — Circle Cardiovascular Imaging (Circle CVI) has announced the expansion of its cvi42 cardiovascular ...

Home March 20, 2026
Home
News | Cardiac Imaging

March 19, 2026 — Heart disease is the leading cause of adult death worldwide, making cardiovascular disease diagnosis ...

Home March 20, 2026
Home
News | Cardiac Imaging

March 16, 2026 — The American Society for Preventive Cardiology (ASPC) will host its 2026 Virtual Imaging Symposium, a ...

Home March 17, 2026
Home
Feature | Cardiac Imaging

Sponsored Content — According to the American Heart Association, cardiovascular disease is the leading cause of death in ...

Home March 13, 2026
Home
News | Cardiac Imaging

March 6, 2026 — Building on its leadership in cardiac MR, Philips has received FDA 510(k) clearance for SmartHeart, an ...

Home March 09, 2026
Home
News | Cardiac Imaging

Feb. 26, 2026 — The U.S. Food and Drug Administration (FDA) has given 510(k) class II clearance of qXR-Detect, the ...

Home February 26, 2026
Home
News | Cardiac Imaging

Feb. 13, 2026 — Conavi Medical Corp. recently highlighted the publication of new peer-reviewed research titled “Deep ...

Home February 16, 2026
Home
News | Cardiac Imaging

Jan. 27. 2026 — Circle Cardiovascular Imaging Inc. has announced the release of cvi42 v6.4, the latest version of its ...

Home January 28, 2026
Home
News | Cardiac Imaging

Jan. 6, 2026 — UltraSight, a provider of AI-guided cardiac imaging workflows, has announced FDA clearance to expand its ...

Home January 16, 2026
Home
Subscribe Now