Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance
Outset Medical, Inc. (OM)
Company Research
Source: Business Wire
SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of TabloCartTM with prefiltration, an innovative optional accessory for the Tablo® Hemodialysis System.Outset has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the United States."With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo Hemodialysis System that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside,” said Leslie Trigg, Chair and CEO of Outset Medical. “Today’s announcement underscores Outset Medical's commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment.”TabloCart is designed to enhance
Show less
Read more
Impact Snapshot
Event Time:
OM
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
OM 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
OM alerts
High impacting Outset Medical, Inc. news events
Weekly update
A roundup of the hottest topics
OM
News
- Analysts Are Updating Their Outset Medical, Inc. (NASDAQ:OM) Estimates After Its First-Quarter Results [Yahoo! Finance]Yahoo! Finance
- Outset Medical, Inc. (NASDAQ:OM) Q1 2024 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Outset Medical, Inc. (OM) Reports Q1 Loss, Misses Revenue Estimates [Yahoo! Finance]Yahoo! Finance
- Outset Medical Reports First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Outset Medical Reports First Quarter 2024 Financial ResultsBusiness Wire
OM
Earnings
- 5/8/24 - Beat
OM
Sec Filings
- 5/17/24 - Form 4
- 5/17/24 - Form 4
- 5/17/24 - Form 4
- OM's page on the SEC website