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Deep Bio Announces Market Authorization from Swissmedic for DeepDx Prostate, Paving the Way for European Expansion
News provided byDeep Bio
Sep 19, 2023, 11:00 AM ET
SEOUL, South Korea, Sept. 19, 2023 /PRNewswire/ -- Deep Bio, a leader in artificial intelligence (AI)-powered cancer diagnostics, announced today that it has obtained marketing authorization from Swissmedic for DeepDx Prostate, its AI-powered prostate cancer diagnostic software.
Swissmedic is the Swiss regulatory authority responsible for the authorization and supervision of therapeutic products. With this key approval, Deep Bio is now eligible to launch DeepDx Prostate in Switzerland, marking a significant milestone in the company's plans to expand its footprint in Europe.
DeepDx Prostate is an AI-powered software for the assessment of prostate cancer on digital whole slide images of hematoxylin and eosin-stained prostate core-needle biopsies. By automating the identification, grading, and quantification of cancerous lesions, this diagnostic software empowers pathologists to make more accurate and efficient prostate cancer diagnoses, reducing subjectivity and turnaround times. DeepDx Prostate is the first in Deep Bio's suite of diagnostic software products that aim to enhance diagnostic accuracy and in turn, optimize clinical management and patient outcomes.
"We are excited to introduce DeepDx Prostate to Switzerland," said Sun Woo Kim, the CEO and founder of Deep Bio. "The expanding list of countries where DeepDx Prostate has gained approval underscores Deep Bio's unwavering commitment to improving global access to high-quality healthcare and advancing prostate cancer diagnosis through AI-driven innovation."
Deep Bio continues to expand its global reach through partnerships with digital pathology leaders in the US, Europe, and India. The company conducts collaborative research with leading US research institutions, including Stanford Medical School and Harvard Dana-Farber Cancer Institute, with its clinical validation studies published in prestigious medical journals, such as Cancers and npj Digital Medicine.
About Deep Bio
Deep Bio Inc. is an AI healthcare company with 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 the efficiency and accuracy of pathologic cancer diagnosis and prognosis.
DeepDx® Prostate is a clinically-validated AI for the assessment of prostate cancer. 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. To learn more, visit http://www.deepbio.co.kr.
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