Author: Deepbio

DeepDx®-Prostate Pro, designated as an Innovative Product by the Korea Public Procurement Service, is expected to improve pathology workflows in real clinical settings

SEOUL, SOUTH KOREA (PRWEB) OCTOBER 10, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics software, announced that it will sign trial purchase agreements with five Korean hospitals for its AI-based prostate cancer diagnosis support software, DeepDx®-Prostate Pro, through the Public Procurement Marketplace program run by the Korean Public Procurement Service (PPS). The software was designated as an ‘Innovative Product’ in July 2022.

To successfully complete the integration of DeepDx®-Prostate Pro into the pathology workflows by this November, the hospitals participating in the trial purchase – the SMG-SNU Boramae Medical Center, Chungnam National University Sejong Hospital, Korea Institute of Radiological & Medical Sciences, Jeju National University Hospital, and Gyeongsang National University Changwon Hospital – and Deep Bio are progressing through required procedures and making arrangements. The AI will be used for various purposes, including support for pathologists in tumor severity determination, confirmation of diagnoses, and research.

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, which empowers pathologists to make diagnostic decisions with increased accuracy and speed.

“We are greatly expecting to prove that our software can be seamlessly integrated into the current pathology workflows, bringing positive changes such as reducing pathologists’ work burden and improving efficiency in real clinical settings,” mentioned Sun-Woo Kim, CEO of Deep Bio. He also said, “through this trial purchase project, Deep Bio will lead the introduction of digital pathology in Korea as well as accelerate domestic market expansion.”

Korea PPS’ ‘Innovative Product Designation Program’ is a government program that aims to foster the development of innovative technologies. To select Innovative Products, a committee made up of the Korea PPS and experts in each field, such as bio-health, future automobiles, and carbon neutrality, evaluates each registrant based on several criteria including public value and innovation.

Focusing not only on AI diagnostics but also 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 platform 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.

Demonstrated globally-recognized standards in safety and quality management as a medical software manufacturer.

SEOUL, SOUTH KOREA (PRWEB) AUGUST 16, 2022 – Deep Bio, a pioneer in medical AI for pathologic cancer diagnostics, announced that it has been recently granted Medical Device Single Audit Program (MDSAP) certificate.

MDSAP is a unified global regulatory audit of medical device manufacturing operated by the International Medical Device Regulators Forum (IMDRF). MDSAP-certified manufacturers are considered to have satisfied the relevant requirements of the regulatory authorities participating in the program including the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).

Through the MDSAP certificate, Deep Bio demonstrated its commitment to high product quality standards and safety management. Also, it is expected that Deep Bio will be able to enter the US, Canada, Japan, Australia, and Brazil markets faster and more efficiently in the future, saving time and cost associated with Quality Management System (QMS) in each market.

“Obtaining MDSAP certification is meaningful in that our products are recognized for outstanding quality management on top of innovative technology in the global market,” said Sun Woo Kim, CEO of Deep Bio. “In particular, as these five countries account for more than half of the global medical device market, I am confident that passing the MDSAP audit can be a great opportunity to expand our presence in overseas markets. At the same time, we will make every effort to strengthen our differentiated technology through continuous product research and establish ourselves as a leader in AI-based cancer diagnostics in global markets,” added he.

Deep Bio continues to focus on not only AI diagnostics but also R&D and presenting the results in various international conferences and events. The company also continues to build its presence in the global market 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 Center, 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.

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.