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Abnormal Heart Rhythm Articles & Analysis

5 news found

FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation

FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation

Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). AF is a heart rhythm disorder that affects nearly 6 million Americans and makes them five times more likely to have a stroke than ...

ByBoston Scientific


Volta Medical’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared

Volta Medical’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared

These annotations help physicians locate heart regions harboring a specific electrogram abnormality, known as spatiotemporal dispersion. This innovative detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to either burn (radiofrequency) or freeze (cryotherapy) ...

ByVolta Medical


Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

This PFA system – comprising a sheath, generator and catheters – is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation. Patients with AF, a common heart rhythm disorder that affects more than 33 million people ...

ByBoston Scientific


Thermedical Announces FDA Breakthrough Device Designation

Thermedical Announces FDA Breakthrough Device Designation

Ventricular tachycardia, which is an abnormally rapid heart rhythm, is a leading cause of sudden cardiac death worldwide. ...

ByThermedical, Inc.


Abbott receives FDA approval for first fully automated blood test for `kissing bug` disease

Abbott receives FDA approval for first fully automated blood test for `kissing bug` disease

The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non–heart-beating) donors. ...

ByCSRwire - Corporate Social Responsibility Newswire

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