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Recently, Alpha Tau Medical announced that its alpha-radiation cancer therapy Alpha DaRT has obtained the Breakthrough Device Designation granted by the US FDA, which is suitable for the treatment of skin and oral scaly without standard treatments.
Cell carcinoma
.
Breakthrough medical devices are a category designed by the US FDA to accelerate the review process and promote the development of clinical trials of devices for the treatment of life-threatening diseases
.
This designation is granted when the device’s preliminary clinical data indicates that it may be more effective than the current standard treatment in terms of clinically significant endpoints of effectiveness, safety or patient quality of life
Note: The original text has been deleted
Reference materials:
[1] Alpha Tau Receives Breakthrough Device Designation from the FDA for Alpha DaRT™.
Retrieved 2021-06-09, from https:// -from-the-fda-for-alpha-dart-301308178.
html
Recently, Alpha Tau Medical announced that its alpha-radiation cancer therapy Alpha DaRT has obtained the Breakthrough Device Designation granted by the US FDA, which is suitable for the treatment of skin and oral scaly without standard treatments.
Cell carcinoma
Breakthrough medical devices are a category designed by the US FDA to accelerate the review process and promote the development of clinical trials of devices for the treatment of life-threatening diseases
.
This designation is granted when the device’s preliminary clinical data indicates that it may be more effective than the current standard treatment in terms of clinically significant endpoints of effectiveness, safety or patient quality of life
Note: The original text has been deleted
Reference materials:
[1] Alpha Tau Receives Breakthrough Device Designation from the FDA for Alpha DaRT™.
Retrieved 2021-06-09, from https:// -from-the-fda-for-alpha-dart-301308178.
html