Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies Innovation Fund (DTIF), to develop CergenX Wave, an automated AI assessment to help detect abnormal brain activity in newborns.
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment.
The ACR-368-tailored OncoSignature assay is being used to identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing, registrational-intent, phase IIb trial in ...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to PreludeDx's DCISionRT test, a risk assessment tool for ductal carcinoma in situ (DCIS), also known as ...
GSK’227 is a novel antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. The Food and Drug Administration (FDA ...
"We are honored to receive Breakthrough Device Designation from the U.S. FDA for our p‑Tau217/β-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more ...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to CergenX’s AI-powered tool for neonatal brain scans. The Irish startup will now be in line for ...
Breakthrough Therapy Designation is generally granted to a drug when evidences suggest that ... You can see the complete list of today’s Zacks #1 Rank stocks here. In the past 90 days, ...
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