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PULSTA Obtains CE MDR CertificationTaeWoong Medical Secures CE MDR Class III Certificationin Europe for Pulmonary Valve ‘PULSTA™’TaeWoong Medical Co., Ltd., a specialized medical device company, announced that its self-developed pulmonary valve product, PULSTA™, has obtained certification under the European medical device regulation CE MDR (Medical Device Regulation).On January 30, TaeWoong Medical held a formal certification award ceremony at its headquarters, where it received CE MDR Regulation (EU) 2017/745 certification from the global notified body BSI.The certified product, PULSTA™, is a high-risk implantable medical device used in patients with complex cardiac conditions. By successfully obtaining Class III certification, which is subject to the most stringent evaluation standards in Europe, the product’s clinical effectiveness and safety have been verified in accordance with European regulatory requirements.Compared to the former Medical Device Directive (MDD), CE MDR significantly strengthens requirements for clinical data as well as post-market surveillance (PMS). Despite ongoing certification bottlenecks for high-risk Class III devices across Europe, Taewoong Medical successfully completed the certification process through BSI, demonstrating its strong technological and regulatory capabilities.A representative of Taewoong Medical stated,“The CE MDR certification of PULSTA™ represents an essential gateway not only to the European market but also to other global markets that recognize or align with MDR standards. Through this achievement, we aim to provide safer and more innovative treatment options for patients and clinicians, while aggressively expanding our commercial presence across Europe.”Read the full article
26.02.05 -
JCIC 2026JCIC 2026(Japanese society of Congential Interventional Cardiology)January 22-24, 2026TaeWoong Medical participated in the 2026 JCIC, successfully completing two PULSTA live cases during the congress. These live cases provided an excellent opportunity to highlight the clinical advantages of PULSTA during actual procedures.At the exhibition booth, 3D heart models of the live case patients were prepared, allowing visitors to take part in an immersive hands-on training experience. Participants were able to directly deploy PULSTA into patient-specific heart models, providing a realistic and practical understanding of the procedure and enhancing engagement through experiential learning.TaeWoong Medical was honored to participate in the 2026 JCIC and appreciated the opportunity to engage with clinicians and industry professionals. We would like to express our sincere gratitude to all participants who visited our booth and showed interest in PULSTA. Taewoong Medical remains committed to advancing structural heart solutions and looks forward to continued collaboration with the clinical community.
26.02.05 -
TaeWoong Medical Newsletter_CONNECT_2025 26.01.07 -
Meet us at JCIC 2026JCIC 2026(Japanese society of Congential Interventional Cardiology)▷ Date : January 22-24, 2026▷ Venue : Kawasaki City Industrial Promotion Hall (66-20 Horikawacho, Saiwai Ward, Kawasaki, Kanagawa 212-0013, Japan)▷ TaeWoong Booth : TBC▷ Website : https://procomu.jp/jcic2026/
25.12.23 -
WCPCCS 2025World Congress of Pediatric Cardiology & Cardiac SurgeryDecember 7-12 2025 Hong KongPULSTA participated with an exhibition booth at the 9th World Congress of Pediatric Cardiology & Cardiac Surgery (WCPCCS), which was held in Hong Kong from December 7 to 12.During the congress, PULSTA_TaeWoong Medical successfully hosted a Lunch Symposium on December 10, welcoming more than 300 attendees. The symposium was titled “Pursuing the Ideal Solution for Dysfunctional RVOT – PULSTA TPV.”The session was moderated by Dr. Mario Carminati and Dr. Jae-Young Choi, with insightful commentary provided by Dr. Sung Ho Kim and Dr. Do Nguyen Tin. Presentations were delivered by Dr. Gi Beom Kim, Dr. Jung Yoon Kim, and Dr. Jou-Kou Wang, who shared valuable clinical experiences and case reviews.Through this symposium, attendees were introduced to PULSTA and gained a clear understanding of its distinctive advantages through case reviews, making it a meaningful opportunity to highlight the clinical value of PULSTA TPV.In addition, the PULSTA booth featured a PULSTA lamp designed to replicate the shape of the PULSTA device. This creative display served as a photo zone and successfully attracted significant interest and engagement from congress participants.
25.12.23 -
APDW 2025Asian Pacific Digestive Week18-22 November 2025Suntec, SingaporeAt APDW 2025 in Singapore (November 18–22), TaeWoong Medical was pleased to participate in one of the region’s most influential gatherings in digestive health, held under the theme “Innovate, Integrate, Invigorate: a new era in Gastroenterology.” The event provided an excellent opportunity to connect with leading gastroenterologists, hepatologists, endoscopists, and GI-surgery specialists, showcasing our evolving device portfolio and sharing our vision for global expansion. Engaging with clinicians, distributors, and industry partners allowed for meaningful exchanges on emerging clinical needs and technology trends, providing valuable insights that guide the development of next-generation endoscopic and stent solutions. We sincerely thank everyone who visited our booth — your interest, feedback, and collaboration reinforce TaeWoong Medical’s commitment to advancing patient care worldwide through continuous innovation.linkedin
25.11.26 -
UEGW 2025UEGW 2025At UEGW 2025 in Berlin (October 4–7), TaeWoong Medical was excited to welcome visitors to Booth 4.47, where we highlighted our growing presence in the global gastrointestinal device market.We enjoyed reconnecting with the GI community, sharing our evolving product portfolio, and discussing our vision for continued global expansion. The event provided a great opportunity to meet clinicians, distributors, and industry partners, and to exchange valuable insights that support ongoing innovation in endoscopic and stent solutions.Thank you to everyone who stopped by — your interest, feedback, and collaboration help us continue advancing care for patients worldwide.
25.10.27 -
CSI AP 2025CSI Asia-Pacific 2025PULSTA participated in the CSI Asia-Pacific 2025, which was held from October 3 to 5, 2025, at the Millennium Hilton Bangkok, Thailand. The booth number was #7, and many visitors were already familiar with PULSTA prior to the event. Following the Live Case session, even more participants visited the booth with great interest. At the booth, visitors had the opportunity to experience the Loading and Deployment Process, and they responded positively, noting that the system was very simple and user-friendly. In addition, when we informed them that the CE approval is expected to be obtained by the end of this year or early next year, they expressed high expectations for the product’s upcoming availability.On October 4, a PULSTA Live Case was performed at Siriraj Hospital. The procedure was conducted by Dr. Krit from Siriraj Hospital, with participation from Dr. Gibeom Kim and Dr. Krit from Chiang Mai.Furthermore, Dr. Kyungseok Lee from Seoul National University Hospital presented data on the durability and safety of PULSTA, based on five years of domestic clinical cases since its commercial launch. As the data covered a long-term follow-up period of five years, this presentation served as a valuable opportunity to demonstrate the long-term durability and reliability of PULSTA.We would like to express our sincere gratitude to all physicians, partners, and visitors for their interest and support of PULSTA during CSI AP 2025. We were honored to share our advancements and vision for the future of PPVI.
25.10.24 -
Meet us at WCPCCS 2025▷ Date : December 7-12, 2025▷ Venue : Hong Kong Convention and Exhibition Centre▷ TaeWoong Booth : #16▷ Website : https://wcpccs2025.org
25.10.24 -
Meet us at APDW 2025▷ Date : November 18-22, 2025▷ Venue : Suntec Singapore Convention & Exhibition Centre (*1 Raffles Boulevard Singapore 039593)▷ TaeWoong Booth : #42▷ Website : https://apdw2025singapore.com/
25.09.19 -
SPED 2025SPED 2025 – Panamerican Digestive Diseases WeekSPED 2025 – Panamerican Digestive Diseases Week Held in Lima, Peru from August 28 to 31, 2025, SPED 2025 brought together over 2,000 professionals from across the continent for an exceptional week of scientific exchange and collaboration. We were honored to participate as an exhibitor and contribute to this landmark event in the field of gastroenterology.
25.09.09 -
Meet us at UEGW 2025▷ Date : October 4-7, 2025▷ Venue : Messe Berlin (Entrance: CityCube) / Messedamm26, 14055 Berlin, Germany▷ TaeWoong Booth : #4.47▷ Website : https://ueg.eu/week
25.08.11 -
JSPCCS 2025JSPCCS 2025The 61st Annual Meeting of the Japanese Society of Pediatric Cardiology and Cardiac Surgery was held in Mie, Japan, from July 10 to 12. We were honored to participate as an exhibitor at JSPCCS 2025. The event provided an excellent opportunity to showcase PULSTA and draw meaningful attention from the medical community. We are optimistic about PULSTA’s future presence and impact in the global market.
25.07.23 -
CSI Frankfurt 2025CSI Frankfurt 2025TaeWoong Medical participated in CSI Frankfurt 2025, held from June 18th to 21st in Frankfurt, Germany. Our booth at CSI Frankfurt 2025 was full of enthusiasm and meaningful interaction as visitors explored our innovative PULSTA valve technology and engaged with our team. We were honored to share our latest clinical experiences and discuss the future of transcatheter pulmonary valve interventions with professionals from around the world. We sincerely thank everyone who visited our booth and supported us during the congress. It was a great pleasure to connect with physicians and partners, and to share our dedication to improving patient care in congenital heart disease.
25.07.23 -
Meet us at SPED 2025▷ Date : August 28-31, 2025▷ Venue : Lima Centro de Convenciones (Av. de la Arqueología 206, San Borja 15021)▷ TaeWoong Booth : #11▷ Website : https://sped2025.org/
25.07.04 -
Digestive Disease Week 2025Digestive Disease Week 2025TaeWoong Medical proudly participated in Digestive Disease Week (DDW) 2025, held from May 3–6 in San Diego, California.Our booth featured five dedicated product stations—Endoscopy, Accessory, RFA, Stent – US, and Stent – Global—each designed to showcase our latest innovations and commitment to advancing gastrointestinal care. We appreciated the enthusiastic engagement and insightful discussions with attendees throughout the event.Thank you to everyone who visited our booth and connected with our team—your support motivates us to continue pushing the boundaries of medical technology.
25.05.19
