The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...

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.

Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) ...

UK-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 ...

Xeltis has developed aXess to improve on infection and reintervention rates compared to other dialysis access approaches.

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 ...

Researchers at University of California San Francisco (UCSF) have developed a single genomic test that can quickly detect ...

Plus, Donald Trump is set to visit the White House to meet with President Joe Biden for a symbolic meeting to signify a ...

“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 ...