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Realheart receives Humanitarian Use Device designation by the FDA

Scandinavian Real Heart has announced 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. 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, it states.
“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.
A total artificial heart
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.
Updated: February 5, 2025, 01:55 pm
Published: January 30, 2025
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