with a new product from 3i Diagnostics receiving a Breakthrough Device Designation. While the US regulator first launched the similar Breakthrough Therapy Designation for innovative medicines six ...
with a new product from 3i Diagnostics receiving a Breakthrough Device Designation.
Researchers at University of California San Francisco (UCSF) have developed a single genomic test that can quickly detect ...
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FDA grants breakthrough device designation for Renovos’ bone graft gelUK-based Renovos Biologics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for Renovite BMP-2 (bone morphogenic protein 2), a synthetic nanoclay ...
Inflammatix has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its TriVerity acute infection and sepsis test system. Featuring the Myrna instrument and ...
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 ...
Plus, Donald Trump is set to visit the White House to meet with President Joe Biden for a symbolic meeting to signify a ...
Johnson & Johnson announced that the U.S. Food and Drug Administration has granted nipocalimab Breakthrough Therapy designation for the ...
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve ...
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq ...
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