FDA evaluating a Software as a Medical Device (SaMD) to aid in the triage and diagnosis of COVID-19

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.

BLUEDOCAITM 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. BLUEDOCAITM 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 which may have the potential to be used with a variety of medical imaging technologies across different hospital settings and locations. The pioneering technology behind BLUEDOCAITM is based on well-established medical image processing research of Russell C Hardie, PhD and Barath Narayanan, PhD and is currently 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 approved the commodity license for BLUEDOCAITM, which will allow for its 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. 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 license of BLUEDOCAITM, Blue Eye Soft is paving their way into international markets.

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, please visit our website at: http://blueyesoft.com

Media Contact:
Raghav Kappagantula, Project Manager; [email protected]

BLUEDOCAITM 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 https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200423-sitrep-94-covid-19.pdf. Accessed July 13, 2020.