Pulse Biosciences Submits 510(K) to U.S. FDA for CellFX™ System
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investors.pulsebiosciences.com
Company Research
Source: Business Wire
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (NASDAQ:PLSE), a novel medical therapy company bringing to market its proprietary CellFX™ System today announced the Premarket Notification 510(k) submission to the U.S. Food and Drug Administration (FDA) for its CellFX System. The Company’s FDA filing requests clearance of the CellFX System for commercial use in common dermatologic procedures to remove general benign lesions including sebaceous hyperplasia (SH), a common but difficult to treat facial lesion and seborrheic keratosis (SK), the most common benign raised pigmented lesion. Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal for FDA 510(k) review is 90 calendar days, not including time required by the Company to respon
Show less
Read more
Impact Snapshot
Event Time:
PLSE
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
PLSE alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
PLSE alerts
High impacting Pulse Biosciences, Inc news events
Weekly update
A roundup of the hottest topics
PLSE
News
- Pulse Biosciences Schedules First Quarter 2024 Financial Results Conference Call for May 7, 2024Business Wire
- Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Pulse Biosciences Announces Plans to Initiate a Rights Offering [Yahoo! Finance]Yahoo! Finance
- Pulse Biosciences Reports Business Updates and Fourth Quarter & Full Year 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
- Pulse Biosciences Reports Business Updates and Fourth Quarter & Full Year 2023 Financial ResultsBusiness Wire
PLSE
Sec Filings
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- 4/23/24 - Form S-3/A
- PLSE's page on the SEC website