Johnson & Johnson receives FDA approval for dual energy ablation catheter
Johnson & Johnson won U.S. FDA approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform, an ablation catheter that can deliver both radiofrequency and pulsed field energy through a single device and is integrated with the CARTO mapping ecosystem. U.S. procedures are set to start after a phased commercial rollout this summer. The approval is an early example of management’s roadmap to introduce pulsed field ablation tools, following cardiovascular medtech sales of almost US$9.0 billion in 2025, and may test how MedTech innovation can offset pricing, tariff, and patent headwinds while leaving near-term pharma and litigation risks unchanged.
FDA cleared J&J dual-energy ablation catheter for U.S. phased rollout.
Context
The company announced a regulatory clearance for a new dual energy ablation platform. Management has planned ongoing pulsed field product rollouts and recorded large cardiovascular medtech sales in 2025. The approval could lead to U.S.…
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