FDA Sets A Date To Review XVIVO’s Lung Perfusion System

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The FDA sets a date to consider Humanitarian Device Exemption for XVIVO's perfusion system for preserving donor lungs. Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs. XVIVO will meet on March 20 with the FDA's Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.

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