SINGAPORE - Media OutReach - 12 October2020 - See-Mode Technologies, aMedTech startup based in Singapore and Australia that seeks to empowerclinicians to better predict stroke, today announced that it has received510(k) clearance from the U.S. Food and Drug Administration (FDA) for its debutproduct, Augmented Vascular Analysis (AVA), a world-first medical ArtificialIntelligence (AI) software for automated analysis and reporting of vascularultrasound scans.
AVA uses deep learning, text recognition, and signalprocessing technologies to assist clinicians in interpreting and reportingvascular ultrasound studies -- typically a manual and error-prone process. Witha single click and in less than a minute, AVA can analyse a full vascularultrasound scan, minimising the need for manual drawings. By significantlyreducing the time taken to analyse images and generate reports, See-Mode's AVAaugments the clinical workflow, resulting in greater overall productivity,accuracy and improved patient outcomes.
"Receiving our first FDA clearance is a huge step forus at See-Mode, which demonstrates the strength of the product we have builtand the robustness of our approach in running clinical studies," said Dr MiladMohammadzadeh, Co-Founder and Director, See-Mode Technologies. "We areextremely thankful to the outstanding group of clinicians who have worked closelywith us to validate our models and build clinical evidence for the regulatoryapproval of AVA and our future products. Riding on this momentum, we will beramping up our plans to bring AVA to the U.S. market within the year, to enableclinicians across the U.S. to do their work more efficiently and analysemedical images with a greater control on quality."
Despite being a highly-preventable disease, strokeremains a leading cause of death and disability around the world. To helpclinicians better predict the risk of stroke and vascular diseases, See-Mode isdeveloping novel solutions to improve the analysis of routinely collectedmedical images such as ultrasound, CT or MRI scans. By applying AI andcomputational models on these medical images, clinicians are able to obtainstroke risk factors that may not be accessible in current clinical practice.
Aside from AVA, See-Mode has been building two othernew products - to detect vulnerable plaque using machine learning and toidentify high-risk blood flow using computational modelling. The startup hascompleted strong proof-of-concepts for both products with collaborators inSingapore and Australia, and multi-centre clinical studies are now beingconducted with partners across Europe and the United States.
See-Mode continues to add more image interpretationand reporting capabilities to AVA and is expanding the product's capabilitiesto new clinical use cases. AVA has been approved by the Singapore HealthSciences Authority (HSA) as a Class B medical device in late 2019 and iscommercially available in Singapore, with ongoing pilots in leading hospitalsin Singapore and Australia. See-Mode is presently pending CE approval for AVAin Europe.
About See-Mode Technologies
See-Mode Technologies is a MedTechstartup with a team of scientists, engineers, and clinicians tackling a leadingcause of death in the world: stroke. See-Mode applies cutting-edge deeplearning and computational modeling techniques on medical images to helpdoctors predict stroke and decide on the optimal treatment for their patients.See-Mode has offices in Singapore and Australia and is backed by prominentventure capital firms in APAC, including MassMutual Ventures, BlackbirdVentures, Cocoon Capital, and SGInnovate. See-Mode's first product, AVA(Augmented Vascular Analysis) has received FDA 510(k) clearance and is approvedby Singapore's Health Sciences Authority as a Class B medical device, whilepending CE approval. The company is currently running clinical studies withmajor stroke centers and research institutes throughout the world. Learn moreat www.see-mode.com