MVision AI Receives MFDS Approval and Market Authorization for South Korea

HELSINKI, Finland – June 14, 2024

MVision AI is pleased to announce that our application for MVision AI Segmentation (Contour+) in South Korea has been accepted by the Ministry of Food and Drug Safety (MFDS) under the “Image Segmentation Application Software” for image analysis algorithms to be used in radiation therapy treatment planning workflows. This approval paves the way for the introduction of our advanced image analysis algorithms in radiation therapy treatment planning workflows across South Korea.

Contour+ accelerates the contouring process, provides guidance toward standardization, enhances consistency and saves time, as confirmed by independent evaluations [1-3] and customer experiences [4]. We have designed Contour+ to steer the clinic’s contouring practice towards consensus and compliance with guidelines.

In South Korea, cancer remains a major public health issue. According to a study published in Cancer Research and Treatment (Eun Hye Park et al., 2024), the number of new cancer diagnoses in 2021 increased by 27,002 cases (10.8%) compared to 2020. In 2021, newly diagnosed cancer cases and deaths from cancer were reported as 277,523 (age-standardized rate [ASR], 289.3 per 100,000) and 82,688 (ASR, 67.6 per 100,000), respectively [5]. The integration of advanced AI solutions like Contour+ in radiation therapy departments is crucial to enhance the efficiency and accuracy of cancer treatment, ensuring patients receive timely and personalized care.

MVision AI’s comprehensive GBS™ solution enhances Radiation Oncology professionals’ expertise in AI contouring together with a robust Return On Investment (ROI) strategy. The solution contains 3 innovative products – Contour+, Guide, and Verify.

“MVision AI and Energy Flow are thrilled to announce our GBS solution’s launch in South Korea. This will significantly reduce contouring time in oncology departments, ensuring standardized and efficient patient care. Our training and validation tools will keep clinical teams updated on best practices. Being selected as the preferred vendor marks an important milestone for MVision as we expand beyond Europe and the US,” says Dharanipathy Rangaraj, CEO of MVision AI. “The MFDS approval in South Korea underscores the effectiveness and potential of our technology. We are dedicated to providing the best possible care to cancer patients worldwide by making our solutions accessible to all radiation oncology professionals.”

“We would like to extend our gratitude to our distributor, Energy Flow, for their invaluable partnership in achieving this approval. Their support has been instrumental in navigating the regulatory landscape and bringing our innovative solutions to the South Korean market,” adds Rangaraj.

“The NCC is one of the most important radiation therapy centers in Korea, and it was also the first place to start proton therapy. The NCC already had a lot of experience with the Auto Contouring System, and it is very encouraging that MVision AI was chosen out of many of those experiences. This will mark the beginning of MVision AI’s record as being evaluated as the best product in the Korean market, taking the top market share,” says Young Lip Chung, Founder of Energy Flow.

For more information on Contour+ and our comprehensive GBS™ solution, please visit MVision.ai or contact us at info@mvision.ai.

About MVision AI

MVision AI is a leading provider of AI-powered solutions for radiation therapy treatment planning. Our mission is to empower Radiation Oncology professionals with cutting-edge technology that can help streamline workflows, enable treatment quality and facilitate more patient-focused care. With a commitment to innovation and excellence, MVision AI continues to advance cancer care through the power of AI.

About Energy Flow

Energy Flow is a supplier specializing in radiation therapy devices established in 2021. Currently, it is supplying products from the IBA Proton system, Theragenics, and SGM to the Korean market, led by MVision AI. In addition, it has an unrivaled team in the field of nuclear safety consulting for radiation therapy devices. The representatives are Chung, Young-Lip, the founder, and Dr. Ji, Young-Hoon, the expert member of the MFDS (Ministry of Food and Drug Safety) in Korea, who is the senior advisor.

Contact Information

Media Contact: Sakthy Edamaruku

Email: sakthy.edamaruku@mvision.ai

MVision AI Headquarters:

Paciuksenkatu 29, 00270, 

Helsinki, Finland

https://mvision.ai

References:

[1] MVision.ai – MVision AI Contour+ (Guideline-Based AI Segmentation): highlights from an independent validation study using a comprehensive and curated data set

[2] MVision.ai – Research Results of MVision AI Contour+ Models’ Clinical Evaluation

[3] MVision.ai – NCCC Evaluation of MVision AI contouring software

[4] MVision.ai – The voice of customer experience: Dr. Giuseppe Sasso, New Zealand

[5] Eun Hye Park et al. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2021. Cancer Res Treat. 2024 Apr;56(2):357-371. doi: 10.4143/crt.2024.253. Epub 2024 Mar 13. PMID: 38487832 PMCID: PMC11016640.

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