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CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation - Vimarsana News

CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation

PRINCETON, N.J., Dec. 28, 2023 -- CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its...

New Hope In Cancer Battle: FDA Grants Breakthrough Device Status To Vivos Inc.'s RadioGel - Vivos (OTC:RDGL) - Vimarsana News

New Hope In Cancer Battle: FDA Grants Breakthrough Device Status To Vivos Inc.'s RadioGel - Vivos (OTC:RDGL)

In a significant advancement for cancer therapy, the Food and Drug Administration (FDA) has awarded RadioGel Precision Radionuclide Therapy the coveted Breakthrough Device Designation.

Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation - Vimarsana News

Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation

Richland WA, Dec. 20, 2023 -- Vivos Inc. , Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a...

ABK Biomedical announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) - Vimarsana News

ABK Biomedical announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)

/PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable...

New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Healthcare - Vimarsana News

New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Healthcare

On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...

Source: mondaq.com