Apple and Fitbit join pilot program to speed new health tech through FDA [The Verge]
FITBIT INC (FIT)
NASDAQ:AMEX Investor Relations:
investor.fitbit.com/overview/default.aspx
Company Research
Source: The Verge
Sidestepping the traditional FDA approval process According to Bloomberg , the Food and Drug Administration has announced the names of nine companies participating in a pilot program that could let them pre-clear products instead of going through the agency’s traditional application process. The program, called Pre-cert, will include Apple, Fitbit, Samsung, Alphabet-owned Verily, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Tidepool. The program had attracted over 100 interested companies, and the FDA made its selections based on factors like company size and risk profile of the product(s). The FDA’s usual timeline for approving new products can often take months, which can delay developers as tech advances faster than the agency can approve it. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” said FDA commissioner Scott Gottlieb . “These pilot participants will help the agency shape
Show less
Read more
Impact Snapshot
Event Time:
FIT
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
FIT 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
FIT alerts
High impacting FITBIT INC news events
Weekly update
A roundup of the hottest topics