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US FDA evaluating a SaMD to aid in the triage and diagnosis of COVID-19

By July 13, 2020July 15th, 2020No Comments

Blue Eye Soft, an innovative IT-solutions and software development company, announced that it has received acknowledgment from the U.S. Food and Drug Administration (FDA) of its pre-submission package for its proprietary artificial intelligence (AI)-driven medical imaging software, BluedocaiTM, to assist with the medical diagnosis of diseases such as COVID-19.


Blue Eye Soft CorporationBLUEDOCAI™ is a clinical decision support tool that uses AI-driven deep learning algorithms to assist radiologists and other healthcare professionals with fast and accurate diagnosis of diseases, such as COVID-19. Bluedocai™ has the capability to rapidly analyze chest X-rays to detect the presence of COVID-19 with >90% accuracy and may therefore help improve the efficiency and accuracy of radiology departments in the wake of the overwhelming workload caused by the COVID-19 pandemic.1

Blue Eye Soft Corp is also developing tools to support the medical diagnosis of other diseases such as pneumonia, pneumothorax, tuberculosis, cancer, and stroke. Bluedocai™ has the potential to be used with a variety of medical imaging technologies across different hospital settings and locations. The pioneering technology behind Bluedocai™ is based on well-established medical image processing research of scientists from University of Dayton, Ohio and is currently exclusively licensed by Blue Eye Soft.

In addition, Blue Eye Soft has announced that the U.S. Department of Commerce Bureau of Industry and Security has granted the commodity classification number (ECCN) for BLUEDOCAI™, clearing the pathway for Blue Eye Soft to international export. The Blue Eye Soft team believes this is an important step forward for a company rooted in South Carolina to be able to export locally developed AI-powered diagnostic technology beyond the United States with potential reach-out from around 16 countries. Srikanth Kodeboyina, CEO of Blue Eye Soft said, “Our team at Blue Eye Soft is looking forward to serving as a pivotal partner for radiology departments worldwide, helping them deliver precise and high-value patient care — even in the challenging times of this ongoing pandemic.”

Following the commodity classification of BLUEDOCAI™, Blue Eye Soft is awaiting FDA approval of its submission for use in clinical settings and topline readouts from ongoing Bluedocai™ pivotal trials.

About AI in Medical Imaging

There is a constant unmet need in radiology departments as imaging data continue to grow exponentially when compared with the number of available trained readers.2 AI-driven medical imaging tools have the potential to transform radiology departments in terms of enhanced productivity, increased diagnostic accuracy, more personalized treatment planning, and ultimately, improved clinical outcomes.2,3 The general principle behind AI-driven medical imaging tools is the ability to rapidly and accurately quantify and provide assessments based on the radiographic characteristics from images using deep-learning algorithms.2,3

About COVID-19

Coronavirus disease 2019 (COVID-19) is caused by the novel severe acute respiratory syndrome coronavirus 2, (SARS-CoV-2). COVID-19 rapidly spread worldwide soon after it was first reported by officials in Wuhan City, China, in December 2019.4

About Blue Eye Soft

Blue Eye Soft, the groundbreaking multinational corporation of South Carolina Research Authority SC Launch, U.S. Air Force Research Labs CSA cohort, and Innosphere Ventures client company, has paired its AI and computer-aided detection expertise with its fast-moving and innovative market approach to solve problems for commercial and government defense departments worldwide.

Forward Looking Statements

This press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,” “expects,” “potential,” “may,” “will,” and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time. Such statements are made with predictions as to future facts and conditions. Forward-looking statements in this press release include statements regarding potential use in multiple disease conditions with different medical imaging techniques and technologies, as well as an improvement in the efficiency of radiology departments.

Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. Blue Eye Soft does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

For more information:

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Media Contact: Raghav Kappagantula, Project Manager

Bluedocai™ and its logo are trademarks of Blue Eye Soft, Inc.
1. Blue Eye Soft. Data on File. 2020.
2. Hosny A, Parmar C, Quackenbush J, et al. Artificial intelligence in radiology. Nat Rev Cancer. 2018;18(8):500-510.
3. Miller DD, Brown EW. How cognitive machines can augment medical imaging. AJR Am J Roentgenol. 2019;212(1):9-14.
4. World Health Organization. Coronavirus disease 2019 (COVID-19). Available at Accessed July 13, 2020.