FDA grants 510(k) clearance for cardiac transducer

The FDA granted a 510(k) clearance to the S4-1 cardiac transducer for Lumify, a smart device powered ultrasound from Royal Philips.

The company announced the clearance in an Oct. 14 news release and at The American College of Emergency Physicians annual meeting in Las Vegas.

Philips said the S4-1 cardiac transducer will allow the Lumify to be used for cardiac imaging. The S4-1 transducer and cable, which weighs 152 grams, is smaller than a smartphone, according to the company.

Philips introduced Lumify in 2015. It is now available for use in ambulatory settings, cardiac and abdominal imaging and OB/GYN and FAST exam pre-sets.

“Lumify is a game-changing innovation,” John Bailitz, MD, and emergency ultrasound physician in Illinois, said in a news release. “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.”