New FDA clearance opens up Philips' smartphone-connected ultrasound to cardiac use cases

By Jonah Comstock
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Phillips received FDA clearance for an additional transducer for its Lumify ultrasound system, a small portable ultrasound that can connect to mobile devices as well as traditional PACS. The newly cleared S4-1 transducer adds cardiac capabilities to the platform and allows physicians to conduct the focused assessment with sonography for trauma, or FAST exam, with the device.

Lumify receved its initial FDA clearance in October 2015 and launched shortly thereafter. That clearance included L12-4 and C5-2 transducers, which allowed physicians to use the system for acute and emergency care, internal medicine, musculoskeletal urgent care, OBGYN care and office practice and allowed them to examine the gall bladder, abdomen, and lungs.

​The system consists of a Lumify transducer, which connects to the app via USB connection; the companion app, available on Android devices; and access to an online support portal that provides users with training resources as well as account management tools.

“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,” Randy Hamlin, VP and Point-of-Care Business Leader for Philips Ultrasound, said in a statement. “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.”

Previously, the device was available to hospitals for a monthly subscription fee of $199. With the announcement of the new transducer, Philips also said it would introduce an alternate, one-time-purchase transaction. The price point for the new option was not disclosed.