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Pulse Biosciences gains FDA IDE for NANOPULSE-AF trial

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Pulse Biosciences gains FDA IDE for NANOPULSE-AF trial

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An announcement from Pulse Biosciences ( (PLSE) ) is now available.

On December 18, 2025, Pulse Biosciences announced that the U.S. Food and Drug Administration approved its Investigational Device Exemption, enabling the company to begin the NANOPULSE-AF clinical study of its nPulse Cardiac Catheter Ablation System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation. The single-arm, multicenter, prospective study will enroll up to 145 patients across as many as 30 sites, including three outside the U.S., to evaluate the safety and effectiveness of the nsPFA-based catheter, which is designed to deliver rapid, circumferential pulmonary vein isolation with lower total energy and potentially reduced collateral injury, building on positive initial results from an ongoing European feasibility study and marking a key milestone in the company’s push to establish its next-generation ablation technology in the global electrophysiology market.

The most recent analyst rating on (PLSE) stock is a Buy with a $22.00 price target. To see the full list of analyst forecasts on Pulse Biosciences stock, see the PLSE Stock Forecast page.

Spark’s Take on PLSE Stock

According to Spark, TipRanks’ AI Analyst, PLSE is a Neutral.

Pulse Biosciences receives a low overall score due to persistent financial challenges such as continuous losses and cash burn. While technical indicators show some positive momentum, the valuation remains unattractive due to negative earnings. The earnings call provided a balanced view with notable advancements in technology and strengthened finances, but increased operational costs remain a concern. The CFO appointment is a positive strategic move but does not significantly affect the overall score.

To see Spark’s full report on PLSE stock, click here.

More about Pulse Biosciences

Pulse Biosciences, Inc. (Nasdaq: PLSE) is a bioelectric medicine company developing its proprietary nPulse nanosecond pulsed field ablation (nsPFA) technology, which delivers non-thermal electrical pulses intended to clear targeted cells while sparing adjacent noncellular tissue. The company is focused on applying this platform primarily to the treatment of atrial fibrillation and select other soft tissue ablation markets where it aims to improve safety, effectiveness and procedural efficiency for both patients and providers.

Average Trading Volume: 175,405

Technical Sentiment Signal: Hold

Current Market Cap: $964.3M

For a thorough assessment of PLSE stock, go to TipRanks’ Stock Analysis page.

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