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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...

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...

Frederick County awarded state grant to provide free laptops for thousands of households - Vimarsana News

Frederick County awarded state grant to provide free laptops for thousands of households

Thousands of qualifying households in Frederick County will receive free laptops paid for by a grant from the Maryland Department of Housing and Community Development.

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
FDA's Proposed Rule For Oversight Of Laboratory Developed Tests: Part II: FDA's Proposed Phaseout Policy – Key Considerations & Open Questions - Healthcare - Vimarsana News

FDA's Proposed Rule For Oversight Of Laboratory Developed Tests: Part II: FDA's Proposed Phaseout Policy – Key Considerations & Open Questions - Healthcare

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs.

Source: mondaq.com