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CoAxia’s NeuroFlo Catheter For Stroke Shot Down By Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA’s Neurological Devices panel found that the benefits of the catheter system do not outweigh the risks for the intended expanded use to treat acute ischemic stroke, and that further studies are needed.

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Zoll Acquires CoAxia Assets In Bid To Revive NeuroFlo Stroke Catheter

CoAxia Inc. did not have the funds to continue after its de novo petition for the NeuroFlo catheter was rejected by FDA for acute ischemic stroke. But Zoll still sees opportunity for the device; now that it owns the technology, the firm plans to design a new pivotal trial to take before the agency.

CoAxia On Last Legs Following Contested FDA Panel Meeting

CoAxia is out of money in the wake of an unfavorable neurological devices panel meeting about its de novo application for expanded use of its NeuroFlo catheter. The firm says FDA mishandled the meeting, the first public panel meeting for a de novo submission.

Regulatory News In Brief

International draft guidance on a single-audit program for device facilities is expected out by the end of the month, ECRI weighs in on UDI proposed rule, and more regulatory updates.

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