New Hope In Cancer Battle: FDA Grants Breakthrough Device Status To Vivos Inc.'s RadioGel
Portfolio Pulse from Javier Hasse
The FDA has granted Breakthrough Device Designation to Vivos Inc.'s RadioGel for treating solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer. RadioGel is an injectable brachytherapy device using yttrium-90 for localized radiation treatment. Vivos Inc. plans to expedite its IDE submission for human clinical trials in collaboration with the Mayo Clinic.
December 21, 2023 | 4:58 pm
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Vivos Inc.'s RadioGel received FDA Breakthrough Device Designation, indicating a significant advancement in the treatment of certain cancer types and potentially accelerating the path to human clinical trials.
The FDA's Breakthrough Device Designation is a positive regulatory milestone for Vivos Inc., likely to be viewed favorably by investors. It suggests a faster development and review process, which could lead to quicker market access and potential revenue generation. The news is directly related to Vivos Inc. and is of high importance due to the impact on the company's product development timeline and market potential.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100