iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device
iRhythm Technologies, Inc. (IRTC)
Last irhythm technologies, inc. earnings: 2/27 04:05 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investors.irhythmtech.com
Company Research
Source: GlobeNewswire
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially available on the market to ship to customers in the United States. “This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s commitment to quality, compliance and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hea
Show less
Read more
Impact Snapshot
Event Time:
IRTC
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
IRTC 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
IRTC alerts
High impacting iRhythm Technologies, Inc. news events
Weekly update
A roundup of the hottest topics
IRTC
News
- iRhythm Technologies to Participate in the Citi 2024 Global Healthcare ConferenceGlobeNewswire
- iRhythm Data Presented at the American Heart Association 2024 Scientific Sessions Reinforce Clinical and Health Economic Value of Zio Long-Term Continuous MonitoringGlobeNewswire
- iRhythm Technologies to Participate in the Wolfe Research 2024 Healthcare ConferenceGlobeNewswire
- IRHYTHM ALERT: Bragar Eagel & Squire, P.C. is Investigating iRhythm Technologies, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the FirmGlobeNewswire
- Here's Why iRhythm Technologies (IRTC) Slid in Q3 [Yahoo! Finance]Yahoo! Finance
IRTC
Earnings
- 10/30/24 - Miss
IRTC
Sec Filings
- 11/14/24 - Form 8-K
- 11/12/24 - Form SC
- 11/12/24 - Form SC
- IRTC's page on the SEC website