Sanarus submits breast biopsy system to FDA:
This article was originally published in Clinica
Sanarus Medical has filed a 510(k) approval application with the US FDA for its Core Tissue Biopsy System. The minimally invasive device is used to obtain biopsy samples from breast lesions and is based on cryosurgery and ultrasound guidance technology developed by Endocare, of Irvine, California. Sanarus of Pleasanton, California, and Endocare are jointly commercialising Endocare's cryosurgical technology for treating breast tumours and gynaecological diseases under an October 1999 agreement. Endocare also has a minority equity position in Sanarus, which plans to file additional applications in the coming months for complementary proprietary platforms for managing and treating different types of breast disease.