The electrophysiology business Abbott (NYSE:ABT) built around its $250 million acquisition of Topera Medical this month warned physicians about the risk that the splines on some of its Firmap catheters could fracture. Abbott EP said it received 16 reports of catheter spline fracture from October 2013 to April 18, for an incidence rate of less than 0.4%. There […]
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October 30, 2014 by Val Kennedy
Topera Medical landed 510(k) clearance from the FDA for the latest incarnation of its 3D Mapping System, featuring the RhythmView workstation and FIRMap diagnostic catheter.
The imaging system uses electrical signals, captured by a multipolar electrophysiology catheter, and creates a 3D image that can more accurately map cardiac arrhythmias.
Topera said it landed a pair of regulatory wins for its FIRMap catheter.
The Palo Alto, Calif.-based medical device company said it won the CE Mark approval in the European Union and 510(k) clearance from the FDA for the device.
Topera said a new backer, New Enterprise Assoc., led a $25 million Series C round first reported by MassDevice.com last month, with an unnamed "strategic industry partner" joining the round.