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Medical Tubing and Extrusion

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ablation

J&J used RWE for expanded indications — and you can, too

August 18, 2023 By Jim Hammerand

A photo of the Biosense Webster ThermoCool SmartTouch ablation catheter.

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions. Real-world evidence (RWE) took a big step forward recently when the FDA approved expanded indications for Johnson & Johnson MedTech ablation catheters. For the first time, the federal medical device safety regulator … [Read more...] about J&J used RWE for expanded indications — and you can, too

Filed Under: Catheters, Regulatory, Uncategorized Tagged With: ablation, Biosense Webster, fda, johnson & johnson medtech

Abbott wins FDA approval for next-gen TactiFlex ablation catheter

May 19, 2023 By Chris Newmarker

This Abbott marketing illustration shows its TactiFlex Ablation Catheter, Sensor Enabled for treating AFib.

Abbott (NYSE: ABT) today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world's first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott's EnSite X EP System, enabling physicians to visualize heart anatomy more … [Read more...] about Abbott wins FDA approval for next-gen TactiFlex ablation catheter

Filed Under: Catheters, Regulatory Tagged With: Abbott, ablation

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