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MedTech Startup See-Mode Technologies Receives FDA Clearance for AI Software That Automatically Analyses and Reports Vascular Ultrasound Scans

SINGAPORE - Media OutReach - 12 October
2020 -  See-Mode Technologies, a
MedTech startup based in Singapore and Australia that seeks to empower
clinicians to better predict stroke, today announced that it has received
510(k) clearance from the U.S. Food and Drug Administration (FDA) for its debut
product, Augmented Vascular Analysis (AVA), a world-first medical Artificial
Intelligence (AI) software for automated analysis and reporting of vascular
ultrasound scans.

AVA uses deep learning, text recognition, and signal
processing technologies to assist clinicians in interpreting and reporting
vascular ultrasound studies -- typically a manual and error-prone process. With
a single click and in less than a minute, AVA can analyse a full vascular
ultrasound scan, minimising the need for manual drawings. By significantly
reducing the time taken to analyse images and generate reports, See-Mode's AVA
augments the clinical workflow, resulting in greater overall productivity,
accuracy and improved patient outcomes.

"Receiving our first FDA clearance is a huge step for
us at See-Mode, which demonstrates the strength of the product we have built
and the robustness of our approach in running clinical studies," said Dr Milad
Mohammadzadeh, Co-Founder and Director, See-Mode Technologies. "We are
extremely thankful to the outstanding group of clinicians who have worked closely
with us to validate our models and build clinical evidence for the regulatory
approval of AVA and our future products. Riding on this momentum, we will be
ramping up our plans to bring AVA to the U.S. market within the year, to enable
clinicians across the U.S. to do their work more efficiently and analyse
medical images with a greater control on quality."

Despite being a highly-preventable disease, stroke
remains a leading cause of death and disability around the world. To help
clinicians better predict the risk of stroke and vascular diseases, See-Mode is
developing novel solutions to improve the analysis of routinely collected
medical images such as ultrasound, CT or MRI scans. By applying AI and
computational models on these medical images, clinicians are able to obtain
stroke risk factors that may not be accessible in current clinical practice.

Aside from AVA, See-Mode has been building two other
new products - to detect vulnerable plaque using machine learning and to
identify high-risk blood flow using computational modelling. The startup has
completed strong proof-of-concepts for both products with collaborators in
Singapore and Australia, and multi-centre clinical studies are now being
conducted with partners across Europe and the United States.

See-Mode continues to add more image interpretation
and reporting capabilities to AVA and is expanding the product's capabilities
to new clinical use cases. AVA has been approved by the Singapore Health
Sciences Authority (HSA) as a Class B medical device in late 2019 and is
commercially available in Singapore, with ongoing pilots in leading hospitals
in Singapore and Australia. See-Mode is presently pending CE approval for AVA
in Europe.

About See-Mode Technologies

See-Mode Technologies is a MedTech
startup with a team of scientists, engineers, and clinicians tackling a leading
cause of death in the world: stroke. See-Mode applies cutting-edge deep
learning and computational modeling techniques on medical images to help
doctors predict stroke and decide on the optimal treatment for their patients.
See-Mode has offices in Singapore and Australia and is backed by prominent
venture capital firms in APAC, including MassMutual Ventures, Blackbird
Ventures, Cocoon Capital, and SGInnovate. See-Mode's first product, AVA
(Augmented Vascular Analysis) has received FDA 510(k) clearance and is approved
by Singapore's Health Sciences Authority as a Class B medical device, while
pending CE approval. The company is currently running clinical studies with
major stroke centers and research institutes throughout the world. Learn more
at www.see-mode.com

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