Pulse Biosciences Updates on Regulatory Progress
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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US:NASDAQ Investor Relations:
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Source: Business Wire
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company), a novel bioelectric medicine company bringing to market its proprietary CellFX™ System, today announced an update to its regulatory timeline with the Food and Drug Administration (FDA). In connection with the ongoing review of the Company’s 510(k) submission for its CellFX System in dermatology, the Company requested a face-to-face meeting with the FDA to discuss its proposed final responses. Due to holiday schedules within the FDA, the meeting is planned for the first half of January. The Company expects to submit its final responses to the FDA following the meeting, and based on FDA feedback, anticipates the 510(k) review to be concluded by the end of January.“We look forward to meeting with the FDA and believe face-to-face meetings are an important part of the regulatory process and are consistent with our efforts to develop a long-term and collaborative relationship with the Agency,” said
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Sec Filings
- 10/31/24 - Form 8-K
- 10/30/24 - Form 10-Q
- 10/30/24 - Form 8-K
- PLSE's page on the SEC website