Mediana Vows Global Expansion with 'Integrated Monitoring Solution'

Oh Yukyung, Commissioner of the Ministry of Food and Drug Safety:
"Supporting the Preemption of the Future Medical Device Market"

Mediana, a subsidiary of Selvas AI, announced on June 11 that Oh Yukyung, Commissioner of the Ministry of Food and Drug Safety, visited the company's headquarters in Wonju on the 10th to inspect the medical device production site and hold a meeting with medical device manufacturers in the Gangwon region.

Kang Dongwon, CEO of Mediana, is explaining the development and production status of the flagship products to Oh Yukyung, Commissioner of the Ministry of Food and Drug Safety, who visited the headquarters in Wonju, Gangwon Province on the 10th. Mediana

This visit was organized as part of efforts to strengthen the global competitiveness of Korea's medical device industry and foster the digital medical device sector through direct communication on site. Commissioner Oh toured Mediana's main production facilities, checked the development and production status of key products, and inspected the company's quality management system.

Mediana is a domestic medical device company that independently develops and manufactures patient monitors and automated external defibrillators (AEDs). More than 75% of its sales are generated overseas, and it supplies products to over 80 countries worldwide. Building on its existing medical device business, the company is expanding into the digital healthcare sector. Mediana has established the 'MEDIANA Unified Monitoring' integrated monitoring solution, which connects patient monitors, wearable medical devices, and central monitoring systems (CMS). The company is also pursuing a medical artificial intelligence (AI)-based platform business.

During the meeting, participants discussed strategies for expanding the overseas presence of Korean medical device companies and regulatory reform challenges. The Ministry of Food and Drug Safety stated its policy to shorten the approval and review periods for innovative products such as new medical devices by expanding specialized personnel for approvals and reviews and restructuring the review system, given that medical devices are a key growth industry for Korea and are advancing through AI and digital convergence. The ministry will also promote and expand systems to reduce the burden of redundant reviews for companies, such as the combined review of domestic GMP (Good Manufacturing Practice for medical devices) and the MDSAP (Medical Device Single Audit Program).

Mediana shared the difficulties it has experienced regarding overseas approvals in emerging markets such as India and the Middle East, and suggested expanding the provision of information on country-specific approval procedures and submission requirements, as well as strengthening regulatory cooperation.

Commissioner Oh said, "We will actively reflect the opinions from the field and expand support so that the domestic medical device industry can continue to secure competitiveness in the global market," adding, "Medical devices that can apply various technologies such as AI and robotics must take on diverse challenges to preempt the future market and become a driving force for national growth."

Kang Dongwon, Chief Business Officer of Mediana, said, "It was a meaningful opportunity to share the technological capabilities and growth potential of domestic medical device manufacturers," adding, "Based on our recently launched integrated monitoring solution, we plan to actively target the market for tertiary hospitals such as national, public, and university hospitals, and secure new growth drivers by creating synergy with our existing patient monitor business."

This content was produced with the assistance of AI translation services.