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FDA/Panel Decisions

Pulse Biosciences Reports IDE Approval To Initiate NsPFA Cardiac Surgery System Study

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Pulse Biosciences (PLSE) announced that the FDA has granted approval for the Investigational Device Exemption, allowing Pulse Biosciences to proceed with the
initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the
treatment of atrial fibrillation. The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA's Total Product Life Cycle Advisory Program.

The company's first-in-human feasibility study has been underway in the EU since August 2024, with over 40 patients treated across three sites in The Netherlands.

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Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.