Jan. 29, 2025 – Scandinavian Real Heart AB (recently aannounced that its total artificial heart, Realheart TAH, has been granted Humanitarian Use Device (HUD) designation by the U.S. Food and Drug Administration (FDA). The HUD designation makes Realheart TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product limited marketing rights.
Realheart TAH is a total artificial heart that mimics the structure and physiological function of the human heart. Following multiple rounds of communication with the FDA, the device has been granted Humanitarian Use Device status which paves the way for Realheart TAH to treat patients with advanced biventricular heart failure who have few other options and need to be supported by a total artificial heart.
HDE is approved if the sponsor can demonstrate data indicating probable safety and benefit to the intended patient group.
Realheart will continue communications with the FDA to develop a clinical investigation strategy to support a Humanitarian Device Exemption premarket approval.
“We are extremely pleased that Realheart® TAH has been granted Humanitarian Use Device designation by the FDA. It is gratifying to look forward to our efforts culminating in such humanitarian benefit. We look forward to updating the market on further clinical and regulatory activities and meanwhile continue our preclinical development which will be important for a potential future full market approval,” says Ina Laura Perkins, CEO of Realheart.
For more information, visit www.realheart.se
January 15, 2026 
