HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment
Heartbeam, Inc. (BEAT)
Last heartbeam, inc. earnings: 2/26 04:05 pm
Check Earnings Report
US:NASDAQ Investor Relations:
gobio.com/investors/news-releases
Company Research
Source: Business Wire
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) OutcomeHeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients Anytime, AnywherePivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias. This clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination.Unlike any single-lead or 6-lead consumer device, HeartBeam’s patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a
Show less
Read more
Impact Snapshot
Event Time:
BEAT
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
BEAT 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
BEAT alerts
High impacting Heartbeam, Inc. news events
Weekly update
A roundup of the hottest topics
BEAT
News
- Credit-Card Sized Device Wins FDA Clearance for At-Home Heart Monitoring [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Top Midday Gainers [Yahoo! Finance]Yahoo! Finance
- HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software ApplicationBusiness Wire
- HeartBeam (BEAT) Recognized as a Top Global Innovator in Portable ECG Technology [Yahoo! Finance]Yahoo! Finance
- Earnings To Watch: HeartBeam Inc (BEAT) Reports Q3 2025 Results [Yahoo! Finance]Yahoo! Finance
BEAT
Earnings
- 11/13/25 - Beat
BEAT
Sec Filings
- 12/19/25 - Form 4
- 11/21/25 - Form 8-K
- 10/3/25 - Form 4
- BEAT's page on the SEC website