Cardio Flow Design, a Japan-based medical application and software firm, has received approval from the US Food and Drug Administration (FDA) for the use of its iTFlow software in blood flow analysis.
iTFlow is said to increase the diagnostic accuracy for individuals with cardiovascular diseases and heart conditions.
The software uses 4D Flow magnetic resonance imaging (MRI) data to support the evaluation in the fields of cardiovascular surgery and radiology.
According to Cardio Flow Design, the FDA approval will allow healthcare professionals to use the software and make more precise and effective decisions in patient care.
Users can conduct their own analysis and blood flow visualisations using the MRI data. It also allows the visualisation of fluid dynamics in the heart and blood vessels in 2D as well as 3D without any contrast agents, the medical application and software firm said.
Additionally, several quantitative evaluations can be performed using factors such as flow rate, pathline, velocity, streamline, and others.
iTFlow combines advanced algorithms and image analysis methods to help doctors and other healthcare professionals make diagnoses and plan treatments.
Cardio Flow Design CEO Teruyasu Nishino said: “We are delighted this software has obtained FDA approval. We have been pursuing the concept of blood flow analysis with 4D flow MRI for many years, and iTFlow encapsulates the essence of this concept.
“With this approval, we believe that healthcare professionals will be able to provide more accurate diagnoses and treatment plans for cardiovascular diseases, especially for children with congenital heart disease, and will save many lives.
“This innovation will change the way of diagnosis and serve as a catalyst to spread the adoption of blood flow analysis worldwide.”
