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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

FDA approval

FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via MedTech Dive

Abbott won FDA approval on September 8 for the TactiFlex Duo Ablation Catheter, Sensor Enabled, which delivers pulsed field and radiofrequency energy from a single tip. Physicians switch between the two modes during a case. Abbott says commercial cases begin in the coming weeks.

The approval rests on the FlexPulse IDE study, presented as a late breaker at the European Society of Cardiology Congress in late August and published in EP Europace. Abbott reported favorable safety and effectiveness in paroxysmal atrial fibrillation.

This is Abbott's second pulsed field product after Volt, approved in 2025. CEO Robert Ford has tied both to winning back electrophysiology share from Boston Scientific, Medtronic and Johnson & Johnson. For a startup building in electrophysiology, the signal is that dual energy has become a feature the incumbents ship rather than a wedge.

Questions & Answers

What is Abbott's TactiFlex Duo Ablation Catheter?

TactiFlex Duo is an Abbott ablation catheter that delivers both pulsed field ablation and radiofrequency energy from a single tip, letting the physician switch modes during an atrial fibrillation procedure. The FDA approved it on September 8, 2026.

What clinical data supported the FDA approval of Abbott's TactiFlex Duo?

Abbott's FlexPulse IDE study supported the approval of TactiFlex Duo. The results were presented as late breaking data at the European Society of Cardiology Congress in late August 2026 and published in EP Europace, showing favorable safety and effectiveness in patients with paroxysmal atrial fibrillation.

How does TactiFlex Duo relate to Abbott's Volt PFA catheter?

Volt, approved in 2025, was Abbott's first pulsed field ablation catheter. TactiFlex Duo, approved September 8, 2026, adds a dual energy option, and Abbott CEO Robert Ford has said both are expected to help Abbott regain electrophysiology market share.

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