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Cardio Catch-Up: Trial Of Abbott’s Volt PFA Begins; IDE Study To Start This Year

 
• By Reed Miller

Abbott is behind rivals Boston Scientific and Medtronic in the race to capture share of the emerging pulsed field ablation market. PFA is set to eventually become the most common cardiac ablation modality because it is safer than radiofrequency or cryoablation.

Abbott Volt PFA
Abbott Volt PFA • Source: Abbott

The first 30 atrial fibrillation ablation procedures with Abbott’s Volt PFA (pulsed field ablation) system have been completed in Australia and Europe as part of a clinical trial to support a CE mark.

The company expects the US Food and Drug Administration to approve its plan for a US clinical trial of Volt...

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Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

More from Medtech Insight

Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.