FDA grants breakthrough device designation to Alpha DaRT for glioblastoma
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The FDA granted breakthrough device designation to Alpha DaRT for treatment of recurrent glioblastoma multiforme.
Alpha DaRT (Alpha Tau Medical) delivers alpha-irradiation to solid tumors via intratumoral insertion of radionuclide radium-224. When the radium decays, its short-lived daughters disperse and emit high-energy alpha particles that destroy the tumor, according to an Alpha Tau Medical-issued press release.
The device is proposed as an adjunct to standard medical therapies for patients with glioblastoma multiforme or as standalone therapy for patients who have exhausted standard therapies.
“As glioblastoma multiforme is such a terrible disease, it is critical that we find new solutions for these patients,” Uzi Sofer, CEO of Alpha Tau Medical, said in the release. “We are thrilled that receipt of the FDA’s breakthrough device designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world — and to bring new hope for [patients with glioblastoma multiforme].”
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