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Cardio Catch-Up: Trial Of Biosense Webster’s Dual-Energy Ablation System Finishes Enrollment

 
• By Reed Miller

On 19 July, Biosense Webster announced the final enrollment in the SmartfIRE trial of its Thermocool Smarttouch SF cardiac ablation catheter with the Trupulse generator and Carto imaging system.

Cardiovascular Catch-Up
• Source: Shutterstock

SmartfIRE, the single-arm study evaluating the Johnson & Johnson/Biosense Webster Thermocool Smarttouch SF dual-energy catheter and Trupulse generator, has completed enrollment about four months after it started.

The trial has enrolled 149 patients with paroxysmal atrial fibrillation across nine centers in Europe, the company announced on 19 July. SmartfIRE began in late February, and the first cases...

Trupulse can deliver either unipolar, biphasic pulsed field ablation (PFA) or radiofrequency (RF) energy for ablation, so electrophysiologists can seamlessly switch the energy source in the middle of the procedure,...

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

 
• By Shubham Singh

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.