Alpha Tau Receives FDA's Breakthrough Device Designation for the Treatment of Recurrent GBM
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Friday, October 8, 2021
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JERUSALEM, Oct. 8, 2021 /PRNewswire/ -- Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiforme (GBM).
Key Points:
- JERUSALEM, Oct. 8, 2021 /PRNewswire/ -- Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiforme (GBM).
- This is the second Breakthrough Device Designation that Alpha Tau has received from the FDA, following its announcement on June 8, 2021 of the receipt of the designation for the treatment of skin cancer without curative standard of cure.
- "This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world."
- Founded in 2016, Alpha Tau Medical Ltd. is an Israeli medical device company that focuses on research, development, and commercialization of the Alpha DaRT for the treatment of solid tumors.