Tecnoideal America’s Haemoconentartors Receive FDA Authorisation

Tecnoideal America has received authorisation from the FDA for their blood volume and concentration devices (haemoconcentrators).  

The device is used during certain surgical procedures, particularly cardiac surgeries, and helps by removing excess fluid from the blood, thus allowing for better management of blood composition during surgeries.  

The compliance division at Amarex collaborated with Tecnoideal America to carry out the essential performance and equivalence assessments.  

The data derived from these examinations indicated that the device is similar to the previous model, resulting in approval.  

Dr. Ahmad Bayat, the Head of Global Regulatory and Clinical Affairs at Amarex, stated, “We worked closely with Tecnoideal to initiate this development by leveraging knowledge learned from past FDA applications and adhering to current FDA recommendations.”  

Dr Bayat went on to add, “This accomplishment demonstrates Amarex’s capacity for successful collaboration and highlights our strength in product development.”  

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