Browsing Tag
FDA 510(K)
6 posts
Co-Diagnostics (Nasdaq: CODX) launches clinical trial for multiplex respiratory test as FDA approval push begins
Co-Diagnostics launches trial for flu, COVID-19, RSV test kit targeting FDA clearance. Learn how it plans to lead in decentralized respiratory diagnostics.
Venus Concept secures FDA 510(k) clearance for Venus NOVA, its next-gen platform redefining non-invasive aesthetics
Find out how Venus Concept’s FDA clearance for Venus NOVA could transform non-invasive body and skin treatments while testing investor confidence in the company’s turnaround.
Is BlinkLab (ASX:BB1) redefining autism diagnosis through smartphones? What its FDA-ready pilot study reveals
BlinkLab's smartphone autism test posts 84% accuracy in pilot study. Find out how close it is to FDA approval and what this means for AI in healthcare.
Median Technologies secures €37.5m EIB funding to advance eyonis AI cancer diagnostics and US launch
Median Technologies secures €37.5M from the European Investment Bank to accelerate AI-driven eyonis® cancer screening software commercialization in the US and EU.
Cleo Diagnostics (ASX:COV) gains PLCO biobank access to strengthen FDA submission for ovarian cancer test
Cleo Diagnostics secures PLCO biobank access to enhance its ovarian cancer test FDA filing. Find out how this milestone strengthens global regulatory strategy.
Game-changing MRI technology: Zynext Ventures bets big on Neuro42’s brain imaging
Zynext Ventures USA LLC, the venture capital arm of Zydus Lifesciences, has made a significant investment in Neuro42…