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SalutarisMD receives FDA clearance for radionuclide brachytherapy source

Issue: September 2015

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BARCELONA — Salutaris Medical Devices has received 510(k) clearance from FDA for its SMD Sr90-1 radionuclide brachytherapy source, according to a press release.

The treatment is indicated for episcleral brachytherapy of tumors and benign growths for use within a manual brachytherapy applicator system, the release said.

At the Ophthalmology Futures European Forum 2015, Laurence Marsteller, MD, CEO of SalutarisMD, presented recent investigational therapy study results from the use of a single dose of episcleral brachytherapy to treat wet age-related macular degeneration.

“The study data are encouraging and bring us closer to offering this novel therapy, which is precise and customized, to patients,” he said in the release.