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Tucson, AZ, announced the FDA has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart (TAH) to be used for destination therapy in addition to its current Premarket Approval (PMA) approval as a bridge to transplant.
The Acticon prosthesis was designated a Humanitarian Use Device by the FDA because severe fecal incontinence affects fewer than 4,000 patients a year in the United States.
Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company's BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy.

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