Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device.
The newly cleared S4-1 transducer is pocket-sized and lightweight, Philips touted, designed to improve sensitivity and provide high-resolution 2D images.
“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,” Philips ultrasound point-of-care biz lead Randy Hamlin said in a press release.
The Lumify system operates on user-supplied internet-connected Android devices which can be used to connect to transducers via USB, controlled through the Lumify app. The system uses cloud sharing technology to access PACS, shared networks and system directories, and are accessible on Philips HealthSuite digital platform.
“Lumify is a game-changing innovation. 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,” Dr. John Bailitz of the Social Media and Critical Care organization said in prepared remarks.
Lumify, which Philips launched last November, is offered as part of a “novel subscription model.”
Customers with subscriptions, which Philips said start at a monthly price of $199, receive equipment from the company without having to purchase it. The basic monthly subscription includes a transducer, application, access to the company’s online portal, warranty and customer support, Philips said.