Peijia Medical has announced that its DCwire micro guidewire has received 510(k) clearance from the US Food and Drug Administration (FDA). The product was independently designed and developed by Achieva Medical, a subsidiary of Peijia.
This milestone represents the first US FDA-cleared product in the company’s portfolio and underscores Peijia’s continued commitment to innovation in the field of neurointerventional medical devices, as stated in a press release.
The clearance is also said to mark a significant step forward in Peijia’s global expansion strategy, enabling its entry into the US market.
“We are delighted to achieve this important milestone with the US FDA clearance of DCwire,” said Yi Zhang, chairman and chief executive officer (CEO) of Peijia. “This accomplishment not only validates our product development capabilities but also lays a strong foundation for the international commercialisation of our neurointerventional portfolio.”
Peijia’s goal is to develop comprehensive treatment solutions for structural heart and neurovascular diseases. The company now has four transcatheter aortic valve implantation (TAVI) systems and close to 20 neurointerventional devices commercialised in China as well as various innovative product candidates at different stages of development.
