FDA Clears 510(k) for Analogic Corp.’s New Handheld Ultrasound System

The U.S. Food and Drug Administration (FDA) has cleared Analogic Corporation’s Sonic Window handheld ultrasound system. 

The device is used for visualizing vasculature and guiding peripheral intravenous access (PIV). The new, ultra-compact ultrasound device provides direct visualization of structures beneath the skin in real time to effectively guide clinicians placing peripheral IVs.

“Improved visualization has been demonstrated to improve first attempt success in PIV insertion. The Sonic Window is an intuitive, handheld visualization tool that allows clinicians to quickly visualize a patient’s vessel location, depth and size,” said Jim Green, president and CEO of Peabody, Mass.-based Analogic. “Intravenous access is often one of the first needs a patient has when medical or surgical intervention is necessary. First stick success has many potential benefits: complication and cost reduction, improved time-to-care and improved patient satisfaction. With the Sonic Window acting as a ‘window through the skin and into the body,’ clinicians are equipped with a portable imaging device that provides clear, easy-to-interpret images on a real-time display.”

Unlike existing portable devices on the market today, the Sonic Window handheld is self-contained and does not have cables and wires connecting a transducer nor does it require a cart or stand to operate, according to the company. The device is the size of a TV remote control and requires only one hand for operation. The system’s controls may be manipulated during scanning without any interruption to the image on the screen. In addition, the handheld portable device has a rechargeable battery and does not need to be plugged in to operate.

“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,” said Green. “The FDA clearance supports our previously announced plan to begin shipments later this summer. We also expect that the Sonic Window platform, which is based on our patented DSIQ technology and incorporates an advanced 2-D (two dimensional) ultrasound imaging array, will form the foundation of a family of products that will address procedure guidance and diagnostic needs in both acute care and physician offices.”

According to data cited by the company, delays in care occur in approximately 25 percent of all patients regardless of care setting due to the inability to establish IV access, and the average number of attempts per patients using traditional techniques of sight and palpitation is 2.18. Estimates range from 300-500 million IV placements per year in the United States., with one in three attempts resulting in failure in adults, and one in two attempts resulting in failure in pediatrics. When traditional insertion methods are compared to image guided access, results show that success rates in the unguided group is 82 percent compared to the image guided group where success rates rise to 97 percent. In addition, the image-guided group attempts to completion drop to 1.7 attempts.