Penumbra announces FDA clearance and launch of detachable embolisation coil
The latest system comprises three technologies: Ruby XL, POD XL, and Packing Coil XL.
06 June 2025
The latest system comprises three technologies: Ruby XL, POD XL, and Packing Coil XL.
Avicenna.ai’s CINA-CSpine and VCF tools for detecting spine pathologies via CT scans previously gained FDA 510(k) clearance in 2024.
Nordic Science Investments spearheaded the funding round, with contributions from other investors.
The acquisition follows See-Mode’s receipt of FDA 510(K) clearance for its AI-powered thyroid ultrasound analysis system in 2024.
The reported action means Chinese firms will be banned from bidding on EU tenders over €5m for a five-year period.
FME secured the FDA's 510(k) clearance last week for the updated HDF-capable system.
All components of the system are assembled in the US at Arthrex Manufacturing South Carolina.
The companies aim to create new possibilities for researchers by combining their technologies for measuring visual attention and neural activity.
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