FDA sets a date to review XVIVO's lung perfusion system

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.

News Well, Humanitarian Device Exemption (HDE), Regulatory/Clearance, Food & Drug Administration (FDA), Organ Transplant

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