T2 Biosystems Submits 510(k) Application to the FDA for Review of T2Bacteria Panel
T2 Biosystems, Inc. (TTOO)
Last t2 biosystems, inc. earnings: 2/24 04:05 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investors.t2biosystems.com/phoenix.zhtml?c=253528&p=irol-faq
Company Research
Source: GlobeNewswire
LEXINGTON, Mass., Sept. 11, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced that it has filed a 510(k) premarket submission for the T2Bacteria Panel with the U.S. Food and Drug Administration (FDA). The T2Bacteria Panel is designed to run on the FDA-cleared T2Dx Instrument. The T2Bacteria Panel, once FDA cleared, combined with the commercially available T2Candida Panel is designed to be the first comprehensive rapid diagnostic solution on the market that identifies pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within 8 hours of blood draw. The premarket submission includes data from the pivotal clinical trial that evaluated the performance of the T2Bacteria Panel compared to blood culture, as well as the performance of the Panel in known bacteria p
Show less
Read more
Impact Snapshot
Event Time:
TTOO
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
TTOO 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
TTOO alerts
High impacting T2 Biosystems, Inc. news events
Weekly update
A roundup of the hottest topics
TTOO
News
- T2 Biosystems shareholders vote to convert $15M CRG debt into equity [Seeking Alpha]Seeking Alpha
- T2 Biosystems Shareholders Vote for CRG Debt Conversion into EquityGlobeNewswire
- T2 Biosystems Announces Extension of Multi-Year Capital Equipment Supplier Agreement with Vizient, Inc. [Yahoo! Finance]Yahoo! Finance
- T2 Biosystems Announces Extension of Multi-Year Capital Equipment Supplier Agreement with Vizient, Inc.GlobeNewswire
- T2 Biosystems Unveils T2Lyme Launch Plans and Provides Additional Business Updates [Yahoo! Finance]Yahoo! Finance
TTOO
Sec Filings
- 4/18/24 - Form 8-K
- 4/16/24 - Form 4
- 4/12/24 - Form 8-K
- TTOO's page on the SEC website