Salutaris Medical Devices has received 510(k) clearance from the FDA for their SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS). The SMD-Sr90-DA RBS device is indicated for episcleral brachytherapy. The device is intended for use within a manual brachytherapy applicator system.
"The SalutarisMD team is quite proud and excited to have reached this important regulatory and commercial milestone. It further validates our company's progress, and advances its clinical research agenda," said Laurence Marsteller, MD, CEO of SalutarisMD.
SalutarisMD is developing a minimally invasive procedure that can be performed in an outpatient setting in approximately 15 minutes. The patented and patent pending technology delivers a single-use brachytherapy procedure. SalutarisMD's technology is being engineered to deliver improved outcomes for wet AMD.