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February 2, 2017

Medtronic receives FDA 510(k) clearance for CardioInsight 3D mapping system

Ireland-based medical device company Medtronic has received the US Food and Drug Administration (FDA) 510(k) clearance for its CardioInsight Noninvasive 3D Mapping System.

Ireland-based medical device company Medtronic has received the US Food and Drug Administration (FDA) 510(k) clearance for its CardioInsight Noninvasive 3D Mapping System.

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The mapping solution is designed to map different heart rhythms in the upper and lower chambers of the heart, as well as provide electroanatomic 3D maps of the organ.

The CardioInsight mapping system is claimed to be non-invasive, contrary to the other mapping procedures, which involve inserting a catheter into the heart through an artery or vein.

"This technology is now poised to drive greater physician insights and new advancements in the study and treatment of infrequent, unstable cardiac rhythms."

The noninvasive technology collects electrocardiogram (ECG) signals from the chest, which are then combined with data from a computed tomography (CT) scan of the heart, to provide 3D electroanatomic maps.

Medtronic purchased CardioInsight in 2015, which was then incorporated into the Cardiac Rhythm and Heart Failure unit of its AF Solutions.

Medtronic AF Solutions vice-president and general manager Colleen Fowler said: "The CardioInsight system further expands the portfolio of solutions available for common and complex arrhythmias.

"This technology, which has been in development for decades, is now poised to drive greater physician insights and new advancements in the study and treatment of infrequent, unstable cardiac rhythms in a noninvasive, patient-friendly manner."

The new system includes a 252-electrode sensor vest, which is to be worn by the patient to integrate body surface electrical data with heart-torso anatomy.

The vest is claimed to align with the patient's body to enable continuous and simultaneous panoramic mapping of both atria or both ventricles.

Medtronic intends to strategically launch the mapping system in the countries where it is cleared.

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  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
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