Salutaris Medical Devices Receives 510(k) Clearance from U.S. FDA for
SMD-Sr90-DA Radionuclide Brachytherapy Source
Tucson, AZ USA (December 20, 2016) — Salutaris Medical Devices, Inc. (SalutarisMD®) has received 510(k) clearance from the U.S. Food and Drug Administration (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.
Dr. Laurence Marsteller, CEO of SalutarisMD, commented, “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.”
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.
Caution: Investigational Device Use Only
SalutarisMD® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a pre-revenue medical device company founded to develop an investigational ophthalmic treatment for wet age-related macular degeneration (wet AMD). HOYA Group announced in March 2015 that it had closed an investment financing in SalutarisMD to further SalutarisMD’s growth strategy. For more information visit www.SalutarisMD.com or www.SalutarisMD.co.uk.
Salutaris Medical Devices, Inc.
4340 N. Campbell Ave.
Tucson, AZ 85718
Salutaris Medical Devices, Ltd.
Level 1, Bessemer Building Imperial College
London SW72AZ +44 (0) 203 282 7166
Joanne Vitali, US Communications Director