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Galvanize wins FDA nod for pulsed electric field endoscopic needle

Galvanize announced today that the FDA granted 510(k) clearance for its Inumi Flex endoscopic needle with the Aliya system for soft tissue ablation.

Inumi Flex expands the Aliya pulsed electric field (PEF) ablation portfolio by enabling minimally invasive endoscopic delivery. This addition complements the previously cleared percutaneous needle for the system. Redwood City, California-based Galvanize — formed in 2022 via a three-way merger — plans to initiate a U.S. rollout soon.

Aliya delivers high-voltage, short-duration electrical energy locally to alter the transmembrane potential of cells. This results in the loss of homeostasis, including non-thermal programmed cell death, without denaturing cellular proteins and the extracellular matrix.

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