CONTACT US   |  (864) 397-5101

FDA evaluating a 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, said a press release issued by the company.

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

BluedocaiTM is also under development to support the medical diagnosis of other diseases such as pneumonia, pneumothorax, tuberculosis, cancer, and stroke. BluedocaiTM has 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 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 BluedocaiTM, 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 BluedocaiTM, Blue Eye Soft is awaiting FDA approval of its submission for use in clinical settings and topline readouts from ongoing BluedocaiTM pivotal trials. 

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

Blue Eye Soft, a 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, the press release said.

Join now to enjoy expanded member benefits!

Enjoy exclusive member content, special events, savings, networking and more

Tamia Sumpter

Tamia is a driven senior undergraduate Bioengineering student currently enrolled at Clemson University. With a strong foundation in her field, she has honed her skills through hands-on experience in research and development at Eli Lilly & Company. During her time in the ADME department, Tamia contributed significantly by working on siRNAs and their applications in finding In Vitro-In Vivo Correlation (IVIVC). Looking ahead, Tamia has set her sights on a promising career in law. She aspires to specialize in Intellectual Property Law, with a particular focus on serving as in-house counsel for leading medical device or pharmaceutical companies. Her enthusiasm for this role is palpable as she prepares to embark on her legal journey! She is also a proud member of the Omicron Phi chapter of Delta Sigma Theta Sorority, Inc., PEER Mentor for Clemson PEER/WiSE, and currently serves as the President of Clemson Bioengineering Organization (CBO). With her unique blend of scientific knowledge and legal interests, Tamia is poised to make a meaningful impact in the healthcare and life sciences industries.