BSD Medical has provided an update on the FDA's review of the company's Humanitarian Device Exemption (HDE) marketing submission for the company’s BSD-2000 Hyperthermia System.
Reportedly, the FDA’s review process continues, and the FDA has submitted additional questions to the company for which the company is preparing responses. The company is unable to predict when the review process will be completed and its ultimate outcome.
The 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 on May 15, 2009.
The HUD for the BSD-2000 confirmed that the intended use population is fewer than 4,000 patients per year. Following receipt of the HUD designation, the company has filed a Humanitarian Device Exemption (HDE) marketing submission with the FDA, and the FDA review process of this submission is ongoing.
The company said that if received, the HDE approval of the BSD-2000 Hyperthermia System would authorise the commercial sale of the BSD-2000 in the US.