This designation marks the Korean government’s recognition of innovation for DeepDx®-Prostate Pro.
SEOUL, SOUTH KOREA (PRWEB) JULY 25, 2022 - Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics software, announced that its AI solution for grading the severity of prostate cancer, DeepDx®-Prostate Pro, has been officially designated as an ‘Innovative Product (Fast Track II)’ by the Korean Public Procurement Service (PPS) in the bio-health sector, a public recognition of product excellence and innovation.
‘Innovative Product Designation Program’ is a government program that aims to foster the development of innovative technologies and is operated by the Korean PPS, providing public access to breakthrough technologies. To select Innovative Products, a committee made up of the Korea PPS and experts in each field, such as bio-health, future automobiles, carbon neutrality, evaluate each registrant based on several criteria including public value and innovation. As a result, Deep Bio can now execute a purchase agreement with the PPS, and the product can be registered in the Public Procurement Market.
With the registration of DeepDx®-Prostate Pro in the Public Procurement Market through this designation, the software as a medical device is now available to more than 300K national- and public institutions for purchase. With this opportunity, Deep Bio is expected to lay the groundwork for market expansion as well as demonstrate the clinical utility of its software.
“We are delighted that the Korean PPS designated DeepDx®-Prostate Pro as an Innovative Product. It represents an official government recognition of the innovation of our state-of-the-art technology. Through this, potential clients at national- and public institutions can better access Deep Bio’s groundbreaking software for purchase”, said Sun-Woo Kim, CEO of Deep Bio. “We also hope that this will be a great opportunity to confirm the robust performance and value of our software when implemented into real clinical workflows,” added he.
DeepDx®-Prostate Pro is a deep learning-based medical software that assists the histopathological diagnosis of prostate cancer by analyzing the Whole Slide Image (WSI) of the prostate needle biopsies. It automatically classifies the severity of prostate cancer based on the Gleason grading system, which is the most widely-used method for evaluating the degree of differentiation of prostate cancer tissues. The software has received Korea MFDS (Ministry of Food and Drug Safety) approval as a Class III medical device in November 2021. In a clinical validation study, the analysis by the software showed high concordance with the reference standard established by experienced board-certified pathologists. In addition, the software improved workflows by significantly reducing time spent by pathologists on analysis of each slide. The study results were published in Modern Pathology.
Focusing not only on AI diagnostics but also on R&D, Deep Bio has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, as well as in various international conferences and events. The company also continues to build its global presence through overseas digital pathology solution providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US.
About Deep Bio
Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio's vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr. DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.