Press release by Flat Medical

Flat Medical Co., Ltd., a MedTech company specializing in safety solutions for anesthesia and critical care procedures, announced that it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), for its brand-new innovation, EpiFaith® CV, to deliver safe central line placements in European markets.

"This is a super exciting achievement for our team with significantly meaningful value," said Shao-Wei Tseng, the Chief Regulatory Officer of Flat Medical. "As the first Taiwanese Medtech company awarded MDR certification from the BSI, we feel honored to be certified to supply our innovative solution to improve the safety and quality of central venous catheterization procedures."

Central venous catheterization (CVC) is a common procedure in anesthesia, emergency medicine, and intensive care practices. Despite being widely performed by physicians in different specialties, central line placement can sometimes become cumbersome and risky when patients are critically ill or in an emergency setting. EpiFaith® CV is an innovative auto-aspiring syringe that helps providers identify and access vessels easily and safely.

As part of its portfolio growth strategy, Flat Medical is announcing the appointment of Dr. Gregory Schears—a Professor at the Mayo Clinic and a world-renowned expert in intensive care and vascular access—to its scientific advisory board. "The EpiFaith® is an innovation that has the potential to help make the central line access a much safer procedure with the user-friendly design," said Dr. Gregory Schears. "I am happy that I can be of help on the development of the product and its clinical strategies."

Flat Medical is now organizing a product launch with its local partners in the U.S. and Europe. The EpiFaith® CV has been formally introduced at the European Society of Anaesthesiology and Intensive Care (ESAIC) annual meeting this June in Milan and will be shown at the upcoming Association for Vascular Access (AVA) annual meeting in Minneapolis, and the European Society of Intensive Care Medicine (ESICM) annual congress in Paris.

Please see the full release here.