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Taiwan's Flat Medical receives MDR certification for European markets

14 July 2022 | News

Flat Medical enters the vascular access medtech domain with its newly acquired MDR certification and new medical advisor

Taiwan's Flat Medical, a MedTech company specializing in safety solutions for anesthesia and critical care procedures, 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.

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.

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.

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