Congratulations to AMDR’s member Innovative Health. They have received FDA clearance for the DuoDecapolar, which is their second product in one week for which they received clearance;
Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for reprocessing the Webster Duo-Decapolar Diagnostic EP Catheter. The 20-electrode EP catheter is used in electrophysiological mapping of cardiac structures, such as in Atrial Fibrillation procedures.
Innovative Health already has clearance to reprocess a large portfolio of Biosense Webster’s diagnostic, ultrasound, and mapping catheters, and the addition of the Webster Duo-Decapolar Diagnostic EP catheter, which has a $1,000 price tag new, represents another important means for EP labs to significantly reduce procedure costs…
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