BSD MEDICAL GRANTED IDE APPROVAL FOR CANCER TREATMENT SYSTEM

The FDA has granted an investigation device exemption for enhancements to BSD Medical's BSD-2000 cancer treatment system.

The BSD-2000 system was designed for difficult-to-treat forms of the disease, including bladder, uterine, cervical, colon, rectal, advanced prostate and lung cancers.

The company said Phase III clinical trials for premarketing approval from the FDA for the BSD-2000 have been completed. BSD is pursuing premarket approval for the product as a complementary device to its BSD-500, which is yet to be approved by the agency. The BSD-500 is intended to treat surface and subsurface tumors.