Pulse Biosciences Gains FDA Approval for NANOCLAMP Study

Pulse Biosciences ( (PLSE) ) has provided an announcement.

On September 8, 2025, Pulse Biosciences announced FDA approval for its Investigational Device Exemption, allowing the initiation of the NANOCLAMP AF study using its nsPFA Cardiac Surgery System for atrial fibrillation treatment. This approval marks a significant milestone for the company, potentially enhancing its industry position by offering a safer and more effective alternative to traditional thermal ablation methods, with the study expected to enroll up to 136 patients across multiple sites.

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 is a bioelectric medicine company focused on health innovation, utilizing its proprietary CellFX nsPFA technology to deliver non-thermal electrical pulses for medical treatments. The company is actively developing this technology for atrial fibrillation treatment and other markets, aiming to improve healthcare outcomes.

Average Trading Volume: 168,638

Technical Sentiment Signal: Buy

Current Market Cap: $1.02B

Find detailed analytics on PLSE stock on TipRanks’ Stock Analysis page.