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