SalutarisMD gets FDA 510(k) clearance for SMD-Sr90-DA Radionuclide Brachytherapy Source
Medical device company Salutaris Medical Devices (SalutarisMD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS).
Planned to be used for a manual brachytherapy applicator system, the SMD-Sr90-DA RBS device can also be utilised for a episcleral brachytherapy procedure.
SalutarisMD's chief executive officer (CEO) Dr Laurence Marsteller said: "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."
The company is currently developing a minimally invasive procedure, which can be performed in an outpatient setting in around 15 minutes. According to SalutarisMD, the patented and patent-pending technology provides a single-use brachytherapy procedure.
In October this year, SalutarisMD obtained a global certification for medical device quality systems, ISO 13485:2003, enabling the company to commercialise its technology to treat wet age-related macular degeneration (wet AMD).
The ISO 13485:2003 certification also includes the design, development, production, and distribution of medical devices produced by SalutarisMD.
A month before receiving the certification, SalutarisMD announced its plan to introduce its new generation, commercial-ready episcleral brachytherapy applicator system.
The new system, SMD-DA, is designed to provide better dosimetry to wet AMD lesions and improved ease of use for retinal surgeons.
SalutarisMD has already obtained US regulatory approval for an upcoming clinical study using the new device.
Image: SalutarisMD SMD-DA applicator. Photo: courtesy of Business Wire.