Peijia Medical receives FDA clearance for DCwire micro guidewire

March 19, 2026 | 14:00

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The Chinese medical device company obtained US regulatory approval for its neurovascular product, enabling American market entry.

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.

For more information about Peijia visit peijiamedical.com/about.

By PR Newswire

Peijia Medical

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