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Analogic Gets FDA Clearance For Handheld Sonic Window Ultrasound System

Analogic Corp. (ALOG) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for the handheld Sonic Window ultrasound system, an imaging device for visualizing vasculature and guiding peripheral intravenous access or 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.

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. The small, lightweight device, which is the size of a TV remote control, 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.

Initial evaluation by clinicians reveals that the Sonic Window incorporates the 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.

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