FDAnews
www.fdanews.com/articles/172916-fda-grants-510k-clearance-to-salutarismd

FDA Grants 510(k) Clearance to SalutarisMD

September 3, 2015

The FDA has granted 510(k) clearance to Salutaris Medical Devices for its SMD Sr90-1 Radionuclide Brachytherapy Source.

The RBS is designed for episcleral brachytherapy of tumors and benign growths, and is intended for use within a manual brachytherapy applicator system.

SalutarisMD CEO Laurence Marsteller said the therapy is precise and customized to patients.

Based in Tucson, Ariz., SalutarisMD is dedicated to developing minimally invasive, patient-centric treatments for vision loss. — Michael Cipriano