Analogic (NSDQ:ALOG) said it won 510(k) clearance from the FDA for its handheld Sonic Window ultrasound device, designed to help caregivers view the vasculature to guide peripheral IV placement.
Peabody, Mass.-based Analogic said the Sonic Window "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," president & CEO Jim Green said in prepared remarks. "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."
Green said Analogic still expects to begin shipping "later this summer," adding that the company plans to use the Sonic Window device as "the foundation of a family of products that will address procedure guidance and diagnostic needs in both acute care and physician offices."
Analogic cited research showing that image-guided IV access increased successful IV placement to 97% and lowered the number of attempts to completion to 1.7, compared with an 82% success rate and 2.2 attempts per completion. The inability to place an IV line delayed care for a quarter of all patients, according to a 1986 study, the company said.