Johnson & Johnson Gains FDA Clearance for Dual-Energy SMARTTOUCH SF Platform
JNJ•Johnson & Johnson received FDA clearance for its THERMOCOOL SMARTTOUCH SF dual-energy ablation platform, combining radiofrequency and pulsed field energy in a single catheter. The device features real-time contact force sensing with 64 sensors and is slated for U.S. commercial launch in Q4 2026.
1. FDA Approval Details
Johnson & Johnson secured FDA clearance for its THERMOCOOL SMARTTOUCH SF dual-energy platform on July 8, 2026, marking its first catheter system to integrate radiofrequency and pulsed field ablation modalities. This approval enables simultaneous energy delivery to optimize lesion formation in atrial fibrillation procedures.
2. Device Technology and Features
The platform features real-time contact force sensing across 64 high-fidelity sensors and proprietary cooling technology to maintain electrode-tissue interface stability. By combining both energy sources, the system aims to reduce procedure times and enhance ablation precision compared to single-energy catheters.
3. Commercial Launch and Competitive Impact
U.S. commercial shipments are scheduled to begin in Q4 2026, targeting electrophysiology labs performing atrial fibrillation ablations. The launch strengthens J&J’s arrhythmia device portfolio against competitors and could drive mid-single-digit annual growth in its electrophysiology business.
