Catheter Precision Announces New FDA 510(k) Clearance for its VIVO System, Enabling Use in a Broader Patient Population

The expanded labeling covers structural heart disease patients undergoing catheter ablation for monomorphic ventricular tachycardia.

Rhea-AI Summary

Flyte Aviation (VJET) subsidiary Catheter Precision received FDA 510(k) clearance expanding the patient population covered by its VIVO system’s labeling. The expanded Indications for Use includes patients with structural heart disease undergoing catheter ablation for monomorphic ventricular tachycardia, a heart rhythm disorder. Structural heart disease involves damaged, scarred, or enlarged heart tissue that disrupts the heart’s electrical pathways.

Catheter Precision said its clinical data demonstrates that VIVO maintains the same accuracy and safety standards in patients with structural heart disease as in those without it. The company also said visualizing patient-specific anatomy before ablation supports planning and can reduce procedure times and improve patient outcomes.

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• Moderate pointFDA 510(k) clearance expands VIVO labeling to structural heart disease patients undergoing ablation for monomorphic ventricular tachycardia.

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Key Terms

510(k) clearance, structural heart disease, monomorphic ventricular tachycardia, catheter ablation

4 terms

510(k) clearance regulatory

"received FDA 510(k) clearance for expanded labeling"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

structural heart disease medical

"individuals with structural heart disease (SHD)"

Structural heart disease describes physical problems with the heart’s valves, walls, chambers or the large vessels that change how blood flows — like a house with broken doors or plumbing that stops water moving correctly. It matters to investors because diagnosing and treating these conditions typically requires specialized devices, procedures and long regulatory reviews, so clinical results, approvals or new technologies can materially affect manufacturers, hospitals and healthcare spending.

monomorphic ventricular tachycardia medical

"catheter ablation for monomorphic ventricular tachycardia (VT)"

A fast, abnormal heart rhythm that starts in the ventricles (the lower chambers) where each heartbeat's electrical pattern looks the same on an electrocardiogram. It usually reflects a single abnormal electrical focus or a stable reentrant circuit in the ventricles that produces a rapid, regular series of wide QRS complexes with an unchanging shape; this distinguishes it from polymorphic ventricular tachycardia, in which the QRS shape varies from beat to beat.

catheter ablation medical

"undergoing catheter ablation for monomorphic ventricular tachycardia"

Catheter ablation is a minimally invasive medical procedure in which a thin, flexible tube is threaded into the heart to destroy tiny areas of tissue that cause abnormal heart rhythms, typically using heat or freezing. Investors watch it because growing use or improved success rates can shift demand for specialized medical devices, hospital procedures and follow-up care, alter treatment costs, and compete with drug or implantable alternatives — like repairing a faulty circuit to restore reliable performance.

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FORT MILL, S.C., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Catheter Precision, a wholly owned subsidiary of Flyte Aviation, Inc. (NYSE American: VJET), today announced that its VIVO system has received FDA 510(k) clearance for expanded labeling in its Indications for Use statement.

The VIVO system is now cleared for a broader patient population, specifically individuals with structural heart disease (SHD) who are undergoing catheter ablation for monomorphic ventricular tachycardia (VT).

Structural Heart Disease (SHD) involves damaged, scarred, or enlarged heart tissue that disrupts the heart's natural electrical pathways. This structural damage frequently triggers severe arrhythmias, such as Ventricular Tachycardia (VT). While standard care relies heavily on implantable defibrillators and medications, catheter ablation remains underutilized due to long procedural times and inconsistent outcomes.

"This expanded U.S. labeling for VIVO is another milestone in delivering enhanced ablation strategies," said David Jenkins, CEO of Catheter Precision. "Our clinical data demonstrates that VIVO maintains the same high standards of accuracy and safety in patients with structural heart disease as it does in those without it. Ventricular ablations are inherently complex, but SHD cases present unique challenges because every patient's anatomy is different. By enabling physicians to visualize a patient's specific anatomy ahead of time, VIVO improves pre-procedural planning, which can reduce overall procedure times and optimize patient outcomes."

About VIVO
Catheter Precision's VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias prior to an electrophysiology procedure, potentially streamlining procedural workflow. VIVO has received marketing clearance from the U.S. FDA and carries the CE Mark.

About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.

About Flyte Aviation, Inc.
Flyte Aviation, Inc. is a holding company for Fly Flyte and Ponderosa Air. Fly Flyte is a technology-enabled private aviation company operating a growing fleet of Cirrus Vision Jets and providing efficient private air travel throughout the United States and select international markets. Through its direct-to-consumer booking platform, standardized pricing on select routes, strategic partnerships, and FAA-certified Part 135 operating subsidiary, Ponderosa Air, LLC, Flyte is delivering a faster, safer and more convenient private aviation experience.

For more information, visit www.flyflyte.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements regarding expected future growth, demand, strategic partnerships, market expansion, brand awareness, aircraft utilization and Flyte’s future operations, are forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially. Readers are encouraged to review the Company’s filings with the Securities and Exchange Commission, including its Forms 10-K and 10-Q, for a discussion of these risks.

Contact
IR@FlyFlyte.com

(800) 763-0904

FAQ

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Which patients does Catheter Precision’s expanded VIVO FDA clearance cover?

The expanded FDA 510(k) clearance covers individuals with structural heart disease who are undergoing catheter ablation for monomorphic ventricular tachycardia. It broadens the patient population included in VIVO’s Indications for Use statement.