Intelligent Bio Solutions Announces 510(k) Submission to US FDA for Fingerprint Sweat-Based Drug Screening Technology
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the submission of its 510(k) premarket notification to the US Food and Drug Administration (FDA) for clearance following FDA review of its Intelligent Fingerprinting Drug Screening System (the "System"), an innovative, rapid and pain-free method for drug screening. The submission represents a critical milestone on the Company’s path to realizing its goal of entering the US market with its drug testing solution in 2025. The Company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the System’s 94.1% accuracy and a Pharmacokinetic (PK) study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on
Show less
Read more
Impact Snapshot
Event Time:
INBS
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
INBS 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
INBS alerts
High impacting Intelligent Bio Solutions Inc. news events
Weekly update
A roundup of the hottest topics
INBS
News
- Intelligent Bio Solutions to Host Virtual Fireside Chat on Wednesday, December 11th at 4:30 p.m. ETGlobeNewswire
- Intelligent Bio Solutions Achieves 94.1% Accuracy in Method Comparison Study, Following Positive PK Study ResultsGlobeNewswire
- Intelligent Bio Solutions to Participate in the Noble Capital Markets’ 20th Annual Emerging Growth Equity ConferenceGlobeNewswire
- Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) SubmissionGlobeNewswire
- Intelligent Bio Solutions Reports Fiscal 2025 First Quarter Financial Results and Operational HighlightsGlobeNewswire
INBS
Sec Filings
- 12/18/24 - Form 8-K
- 12/3/24 - Form 8-K
- 11/26/24 - Form 8-K
- INBS's page on the SEC website