DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical's Global Expansion

SUZHOU, China, March 18, 2026 /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its DCwire^® Micro Guidewire has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") on March 17, 2026. The product was independently designed and developed by Achieva Medical Limited, a subsidiary of the Company.

This milestone represents the first FDA-cleared product in the Company's portfolio and underscores Peijia Medical's continued commitment to innovation in the field of neurointerventional medical devices. The clearance also marks a significant step forward in the Company's global expansion strategy, enabling its entry into the U.S. market.

"We are delighted to achieve this important milestone with the FDA clearance of DCwire^®," said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. "This accomplishment not only validates our product development capabilities but also lays a strong foundation for the international commercialization of our neurointerventional portfolio."

Peijia Medical remains committed to delivering high-quality, innovative medical technologies to patients worldwide and will continue to strengthen its presence in key international markets.

About the Company

Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has four TAVR systems and near twenty neurointerventional devices commercialized in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those expressed or implied in such statements.

source: Peijia Medical