Affera, Medtronic and FDA

Medtronic wins FDA approval for Affera mapping and ablation system
Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.
FDA approves Medtronic's Affera all-in-one pulsed field ablation system
Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation, Medtronic has done it again. | Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation for afib,
Medtronic’s Affera PFA snags FDA approval
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
Medtronic’s Innovative Affera System Gains FDA Approval, Boosting EP Market Prospects
Analyst Travis Steed from Bank of America Securities maintained a Buy rating on Medtronic (MDT – Research Report) and keeping the price
Medtronic Gets FDA Approval for Affera Technology
Medtronic said the Food and Drug Administration approved its Affera mapping and ablation system with sphere-9 catheter.
FDA says Medtronic can study Affera pulsed field ablation system for treating ventricular tachycardia
Medtronic (NYSE: MDT) announced today that the FDA approved an early feasibility study to evaluate its Affera system for treating VT.
Medtronic’s Sphere-9: Promising FDA Approval Amidst Production Uncertainties
Needham analyst Michael Matson has maintained their neutral stance on MDT stock, giving a Hold rating today. Michael Matson’s rating is
A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter,
FDA approves Medtronic’s Affera system for VT treatment study
The study aims to assess the Catheter and Affera system in patients who have ventricular tachycardia (VT) due to scarring from a previous myocardial infarction.
FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter
Medtronic received FDA approval for the Affera mapping and ablation system and Sphere-9 catheter, which can deliver both PFA and RF energy.
Medtronic’s Affera ablation system granted FDA approval
Medtronic (MDT) announced FDA approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density mapping
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FDA approves Medtronic’s Affera mapping and ablation system with Sphere-9 catheter
This approval is expected to help in treatment of persistent AFib and for RF ablation of CTI dependent atrial flutter.
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Medtronic to evaluate Affera in ventricular tachycardia
The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in ...