Topera has secured 510(k) clearance from the FDA and CE mark approval in Europe to market its FIRMap catheter. The device uses the company's RhythmView 3D-mapping workstation, which already has regulatory approval, to map the heart's electrical activity and aid electrophysiologists in treating patients with cardiac arrhythmias.
Topera gets 2 regulatory nods for FIRMap catheter
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