(Reuters) – the Medical doctors BSD systems manufacturer Corp said on Monday that the health of United States regulator approved his device to treat the cancer of uterus.
The BSD-2000 Hyperthermia System, also received the status of exemption as a humanitarian device (HDE for its acronym in English), which usually allow a maker of devices to gain authorization without the requirements of effectiveness resulting from a regular application.
The device is for use with radiation therapy in patients who would be normally treated with a combination of chemotherapy and radiation but not eligible for chemotherapy by certain factors.
Approval with HDE is provided to a company since it demonstrates the safety of your product and the likely benefit to the treatment of a disease that annually affects fewer than 4,000 people in United States.
In 2010, around 12.200 American women were diagnosed with cervical cancer or neck of the uterus and a few 4,210 were killed by the disease.
According to BSD, it is estimated that every year in United States spend nearly 1.4 billion dollars in treatments for cancer cervical.
(Report of Balaji Sridharan in Bangalore); (Edited by Ana Laura Mitidieri in Spanish)
