US-based Analogic has obtained US Food and Drug Administration (FDA) 510(k) approval for its Sonic Window ultrasound system, a handheld ultra-compact imaging device for visualising vasculature and guiding peripheral intravenous access.
The Sonic Window ultrasound system is based on DSIQ technology and incorporates an advanced 2D ultrasound imaging array. The system effectively guides clinicians to place peripheral IVs by providing direct visualisation of structures beneath the skin in real-time.
According to the company, the self-contained device does not have cables and wires connecting a transducer, and does not require a cart or stand to operate.
In addition, the handheld portable device does not need to be plugged in to operate as it has a rechargeable battery. It is lightweight, the size of a TV remote control and requires only one hand to operate.
During scanning, the system's controls may be manipulated without any interruption to the image on the screen, the company added.
Initial evaluation by clinicians reveals that the Sonic Window combines benefits of breakthrough ultrasound imaging technology with portability, making it an efficient tool to use in a clinical setting for the successful establishment of PIV in the patient with challenging IV access.
Analogic president and CEO Jim Green said that the Sonic Window provides clinicians with accurate depth measurement, allowing them to choose the appropriate catheter size and length.
"We are confident that the innovative Sonic Window handheld will offer clinicians a valuable tool for vascular access applications," Green said. "The FDA clearance supports our previously announced plan to begin shipments later this summer.
"We also expect that the Sonic Window platform will form the foundation of a family of products that will address procedure guidance and diagnostic needs in both acute care and physician offices."