FDA Approval for Truefield
Seeing Machines Limited
15 August 2007
15 August 2007
Seeing Machines Limited
('Seeing Machines' or the 'Company')
SEEING MACHINES RECEIVES FDA CLEARANCE FOR TRUEFIELD ANALYZER
Seeing Machines (AIM: SEE), a leading developer of advanced computer based
imaging software systems, announces today that it has received marketing
clearance from the United States Food and Drug Administration (FDA) for its
revolutionary new medical device, the TrueField(R) Analyzer (TFA).
The TFA helps doctors measure defects in a patient's visual field, a crucial
step in the detection and management of diseases of the vision system, including
for example, glaucoma. The TFA offers many outstanding new benefits to both the
patient and the doctor. Most importantly the device is both objective and it is
quick and easy for the patient and operator.
Unlike traditional standard automated perimetry (SAP) devices, the TFA measures
both eyes concurrently, and does the entire test of both eyes in approximately 5
minutes (including rest breaks within the test). The objectivity of the TFA test
offers doctors the possibility of significant improvements over the test-retest
variability issues that impact SAP. For patients it means an end to the button
pressing associated with SAP - the only task required of the patient in the TFA
test is simply to look at the display.
The clearance of the device by the FDA satisfies this regulatory hurdle and
allows the TFA to be commercially introduced into the United States market - the
largest healthcare market in the world. Receipt of this FDA clearance allows us
to remain on track to meet our original objective of launching the TFA in late
2007, and as such the device will be exhibited at the upcoming Annual Meeting of
the American Academy of Ophthalmology in New Orleans in November 2007.
Dr Nick Cerneaz, CEO of Seeing Machines commented: 'Clearance by the FDA is a
tremendously important milestone in the development of both the TrueField
Analyzer and indeed our Company. Achieving FDA clearance has been an important
hurdle along the path to the commercialization of our vision testing technology
and it paves the way for the introduction of the TFA to the highly significant
US market.'
'The TFA was first exhibited at the ARVO 2007 trade show in Ft. Lauderdale,
Florida in May this year (see: http://www.truefield-analyzer.com/arvo2007.html)
and the outstanding response from the clinical and academic community at that
meeting was very encouraging. With the FDA clearance received today we are well
on the way to realizing a highly significant element of our company's strategic
vision.'
Further information about the TrueField Analyzer(R) can be obtained from the web
site: www.truefield-analyzer.com. Further information about Seeing Machines can
be obtained from the company website www.seeingmachines.com.
--- ENDS ---
Enquiries:
Seeing Machines Limited Insinger de Beaufort Parkgreen Communications
Nick Cerneaz, CEO Peter Ward Justine Howarth
+61 (0) 2 6125 6501 +44 (0) 20 7190 7015 +44 (0) 20 7851 7480
www.seeingmachines.com
Notes to editors:
About Seeing Machines
Seeing Machines is an award winning Technology Company which focuses on vision
based human machine interfaces. Formed in 2000 in Canberra, Australia, Seeing
Machines' purpose is to commercialise its computer-vision across a range of
industries and applications.
Seeing Machines deliver advanced computer vision solutions for researches and
developers in human factors, transportation safety, computer human interaction,
robotics, medical research and psychology. The flagship product faceLAB(R)
provides an automated and contact-free gaze and head tracking technology, it
solves the problem of observing human behaviour naturally, non-intrusively and
with a high degree of accuracy and usability. Building on these unique face
tracking and pupil measurement and monitoring capabilities, the TrueField
Analyzer(R) is a development undertaken by Seeing Machines in partnership with
colleagues from the Research School of Biological Sciences (RSBS) at the
Australian National University (ANU).
The TrueField Analyzer(R) offers a new objective method to help doctors diagnose
and manage a range of eye diseases including glaucoma, age related macular
degeneration and diabetic retinopathy. Glaucoma affects about 2-3% of the
population over 40 years of age and is a leading source of blindness. Unlike
most other devices available to the clinician the TrueField Analyzer is a
completely objective test and it is quick and easy for patients and technicians
alike. The device measures both eyes concurrently and due to the reliability
that arises from the objective nature of the test, it has the potential to
become a new standard in the measurement of visual field defects and thus in the
diagnosis and management of disease such as glaucoma.
More generally Seeing Machines' computer vision systems are able to measure the
orientation and position of a human head, estimate eye-gaze direction, detect
eye blinks and track other facial features. This functionality is achieved
entirely though visual means, using video cameras connected to advanced image
processing software, with no attachments required on the subject. Products such
as faceLAB(R) are designed to allow human factors researchers and designers to
assess the interaction of an operator in an environment and this finds
application in designing operator environments, such as cockpits for cars,
trucks, trains, and aeroplanes for instance, and other industrial design
applications, as well as medical and psychological research situations. The
technology also has application in monitoring automobile drivers and if it
detects drowsiness or that the driver is distracted and their attention has been
diverted from the road, an alarm can be raised to alert the driver to either
pull over and rest in the case of drowsiness or to pay more attention to the
road.
The systems work in real-time, enabling the behaviour of subjects to be tracked
in real-time. This technology is paving the way in promoting safer driving
conditions and works to enhance the driving experience and to eliminate
accidents caused through driver drowsiness or distraction.
There are many different sectors that can benefit from this revolutionary
software, for which it has been developed, including: automotive; academic
research; medicine/healthcare; defence; autostereoscopy (next generation
displays); sport; and games.
This information is provided by RNS
The company news service from the London Stock Exchange
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