Du är här

2014-04-09

Analogic Corporation: Analogic Announces FDA Clearance for Breakthrough Sonic Window Handheld

First-of-a-Kind Ultrasound System Initially Targeted for Image-Guided Peripheral Intravenous Access (PIV); Fits in Clinicians' PocketPEABODY, Mass., April 9, 2014 (GLOBE NEWSWIRE) --Analogic
Corporation(Nasdaq:ALOG), enabling the world's medical imaging and aviation
security technology, announced today that it has received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) for the handheldSonic
Window(TM) ultrasound system, an imaging device 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 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. 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.

"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," continued 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 2D 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."

About PIV

Care delays occur in approximately 25 percent of all patients regardless of
care setting due to the inability to establish IV access according to Barton,
AJ (1986), 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 U.S., with one in three attempts
resulting in failure in adults, and one in two attempts resulting in failure
in pediatrics. According to Constantino, TG (2005), 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.

About Analogic

Analogic(Nasdaq:ALOG) provides leading-edge healthcare and security technology
solutions to advance the practice of medicine and save lives. We are
recognized around the world for advanced imaging systems and technology that
enable computed tomography (CT), ultrasound, digital mammography, and
magnetic resonance imaging (MRI), as well as automated threat detection for
aviation security. Our CT, MRI, digital mammography, and ultrasound
transducer products are sold to original equipment manufacturers (OEMs),
providing state-of-the-art capability and enabling them to enter new markets
and expand their existing market presence. Our market-leading BK Medical and
Ultrasonix branded ultrasound systems, used in procedure-driven markets such
as urology, surgery, and point-of-care, are sold to clinical end users
through our direct sales force. For over 40 years we've enabled customers to
thrive, improving the health and enhancing the safety of people around the
world. Analogic is headquartered just north of Boston, Massachusetts. For
more information on the New Sonic Window,
visitwww.analogicultrasound.com/sonicwindow.

Analogic is a registered trademark of Analogic Corporation.

The globe logo is a trademark of Analogic Corporation.

CONTACT: For Further Information, Contact:

Media Contact:
Amy Cook
(925) 552-7893
amycook@amcpublicrelations.com

Investor Contact:
Mark Namaroff
Director of Investor Relations
(978) 326-4058
investorrelations@analogic.com

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Analogic Corporation via Globenewswire

HUG#1776005

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.