FDA issues 510(k) clearance for Getinge's Talis +ACG software [Yahoo! Finance]
GETINGE AB UNSP/ADR (GNGBY)
NASDAQ:AMEX Investor Relations:
getinge.com/int/about-us/investors
Company Research
Source: Yahoo! Finance
The software suite, which includes Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView, and Talis-ECMO applications, is designed to enhance the quality of high-acuity care in the US and EU. The FDA clearance represents a major step forward in providing digital tools for healthcare professionals to assist in adhering to medical facility care protocols while complying with hospital safety practices through alarm and advisory notifications. Getinge has also confirmed with TUV SUD, an EU-notified body, that the Talis products are classified as non-device software in the EU. Getinge Talis Clinical president Gary Colister said: “This classification, enables us to market the suite of Talis Clinical applications as non-device software in Europe, enhancing the quality of care across EU member states.” The Talis +ACG/+PCS software applications are specifically engineered to support hospital-defined clinical and operational process controls. Once properly configured, these controls ca
Show less
Read more
Impact Snapshot
Event Time:
GNGBY
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
GNGBY 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
GNGBY alerts
High impacting GETINGE AB UNSP/ADR news events
Weekly update
A roundup of the hottest topics
GNGBY
News
- Getinge limits sale of heart devices in the US after FDA warning [Reuters]Reuters
- Getinge's financial target 2024-2028: Adjusted EPS growth of above 12% on average [Yahoo! Finance]Yahoo! Finance
- FDA Roundup: May 10, 2024 [Yahoo! Finance]Yahoo! Finance
- FDA issues warning on Getinge device amid quality concerns [Yahoo! Finance]Yahoo! Finance
- US FDA recommends healthcare providers switch from Getinge's heart devices [Reuters]Reuters