|[January 24, 2013]
Welch Allyn iExaminer™ Receives 510(k) Clearance from the United States Food and Drug Administration
SKANEATELES FALLS, N.Y. --(Business Wire)--
Allyn, a leading medical diagnostic device company that specializes
in helping clinicians improve patient outcomes, today announced it has
received 510(k) clearance from the United States Food and Drug
Administration (FDA) for the Welch
Allyn iExaminer™-a product that consists of a hardware adapter and
associated software that allows healthcare providers to capture, store,
send and retrieve images from the Welch
Allyn PanOptic™ Ophthalmoscope using the iPhone (News - Alert)® 4 or 4S. The
PanOptic features patented optical technology that creates a viewing
area of the fundus and retinal nerve in an undilated pupil that is 5
times larger than that of a traditional ophthalmoscope and increases
magnification by 26 percent to more easily see retinal details.
Available for shipment on February 11, the iExaminer rapidly captures
and transmits the retinal images created by the PanOptic for easy,
cost-effective eyeground image documentation.
Welch Allyn iExaminer(TM) (Photo: Busness Wire)
"The iExaminer allows healthcare providers to easily capture and share
the images of a fundus in a moment's notice, helping to improve the
quality of care provided-especially for remote users who may not have
easy access to specialists," said Rick Farchione, senior manager,
physical assessment at Welch Allyn. "It will increase workflow
efficiency by allowing providers to capture and share images from any
clinical environment. It is a low-cost way to digitally capture eye
imaging and will also make it easier for providers to share images with
their patients, helping to improve patient knowledge and compliance."
The iExaminer adapter aligns the optical access of the PanOptic to the
visual axis of the iPhone 4 or 4S camera to capture high resolution
pictures of a patient's fundus and retinal nerve. The iExaminer software
application, available from the Apple (News - Alert) App Store, then allows physicians
to save images to a patient file, as well as e-mail and print the images.
"This is the first affordable device to give almost anyone, anywhere the
ability to capture a picture of the back of the eye," said Dr. Wyche
Coleman, inventor of the iExaminer. "I was able to take this very
lightweight, portable, inexpensive iExaminer to the summit of Mount
Kilimanjaro in sub-Saharan Africa and take a picture of a patient's
fundus. From the top of the mountain, I then transmitted it to a doctor
at Johns Hopkins University in the United States where he was able to
analyze the image."
About the PanOptic™ Ophthalmoscope
The Welch Allyn PanOptic Ophthalmoscope features the patented Axial
PointSource™ Optics that gives healthcare professionals a dramatically
wider, more panoramic view of the retina, or fundus, of the eye. The
technology provides a 25 degree field-of-view, making it possible to see
the different features of the fundus more efficiently than the 5 degree
field-of-view provided by a standard ophthalmoscope. The design also
creates a much greater working distance between the provider and the
patient, greatly improving the comfort level of both during the exam,
while at the same time delivers a 26 percent increase in magnification
to make it easier to see retinal details. The PanOptic works with all
Welch Allyn 3.5 volt power source handles.
About Welch Allyn
Welch Allyn is a leading global healthcare company that offers a
complete range of digital and connected diagnostic solutions that helps
reduce risk and enhance workflow in a variety of clinical settings.
Founded in 1915 and headquartered in Skaneateles Falls, N.Y. (USA),
Welch Allyn is a family-owned business that employs nearly 2,700
employees in 26 different countries. The company specializes in helping
doctors, nurses and other frontline practitioners across the globe
enhance care by developing innovative products, breakthrough
technologies and cutting-edge solutions that improve patient outcomes,
safety and satisfaction. More information about Welch Allyn and its
complete line of connected products and solutions may be found at www.welchallyn.com.
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