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Obtaining FDA approval can be a difficult and long process. “The traditional paradigm of medical device regulation was not designed for adaptive AI or ML technologies, which have the potential to adapt and optimize device performance in real – time to continuously improve healthcare for patients,” the report said.

“The highly iterative, autonomous, and adaptive nature of these tools requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards.”

The guidelines in the report aren't set in stone, however. At the moment the framework is a proposal and the FDA is looking for feedback before any policies are implemented

https://www.theregister.co.uk/2019/04/03/fda_ai_health/

Must have very large orders for stock from USA!

USA know the importance of FDA approval!

More News on the Sales next week!

IQ-AI Limited’s (LON:IQAI) David Smith caught up with Proactive London's Andrew Scott after announcing that Imaging Biometrics has signed a non-exclusive business development and sales deal with brain analysis firm CorTechs Labs.

Smith says the deal gives them extended and immediate sales representation in the US and other international markets.

He adds that product sales have continued to accelerate in 2019 and as a result they're expecting full year 2019 numbers to be more than double those for 2018.

https://www.proactiveinvestors.co.uk/companies/news/313709/iq-ai-on-track-to-double-sales-in-2019-as-it-inks-deal-with-cortechs-labs-13709.html

Market Manipulation at it's best!

Crooked MM's

The fact that FDA approval for Stonechecker software has taken so long shows how rigorous the process is, how advanced the product is, and also what a great achievement approval will be.
And one that will be monumental for IQAI's development, because America is such a vast and well-funded healthcare market, which is at the forefront of applying new technology.

This won't therefore be your 'average' good news: it will be gold-plated, company-transformative, 'talk of the town' news.

Therefore, I think that we can expect a very big immediate rerating upwards in the share price ... but that should be just for starters.
The general upward momentum could continue for weeks, months, and years.

And in terms of business, IQAI is chaffing at the bit to start selling StoneChecker into the multi trillion dollar US healthcare market, and has been investing into its business ahead of that, a very positive sign.

IQAI also appears to have a range of potential US reseller agreements lined up, which could be ready for signing once FDA marketing approval is received, if not earlier.

In effect, the FDA approval will be like removing a 'plug' to unleash a stream of positive IQAI newsflow.

So I would certainly anticipate that the IQAI s.p. will hit multiples of its current level in the not too distant future.

Far too cheap!

Watch Mcap double or triple next week!

More than 300 million patients worldwide suffer with kidney stones and the majority of these are working age adults. Despite these numbers, relatively little funding is given to research and development in this field. Stone Checker Software Ltd aims to address this unmet clinical need by providing novel products for the healthcare market. Stone Checker Software Ltd is wholly owned by IQ-AI Ltd; a publicly-listed company on the London Stock Exchange: IQAI.

Stone Checker Software Ltd has an exclusive worldwide licence to apply the TexRAD® algorithm (provided by TexRAD Ltd., www.TexRAD.com, part of Feedback Plc) to examine heterogeneity and ‘texture’ not visible to the naked eye. Tested and validated at the University of Oxford, StoneChecker software has been available for research use since 2017 and is now available for commercial use outside the U.S.

The company said it would issue an update outlining the scale of the opportunity along with its product roll-out plans in the next few days.

15p next week on above news!

They’ve been waiting for years for FDA clearance

https://www.google.co.uk/amp/s/www.proactiveinvestors.co.uk/companies/amp/news/903628

IQ-AI Ltd (LON:IQAI) said it has received the regulatory green light in America for its StoneChecker software, which is used to assess kidney stones.

Imaging Biometrics, the company’s Milwaukee-based subsidiary, was granted “clearance to market” by the US Food & Drug Administration.

The company said it would issue an update outlining the scale of the opportunity along with its product roll-out plans in the next few days.

IQ-AI shares surged 41% to 6.65p on Friday morning.

Ajed

Read Here:

https://www.rte.ie/news/business/2019/0912/1075416-providence-resources-results/

The chief executive of Providence Resources has said he fundamentally believes that a $9m loan from its Chinese backers will be delivered.

Tony O'Reilly jr told shareholders at the company's AGM in Dublin that he has staked his reputation on the issue.

Mr O'Reilly said he understood it seemed incredulous that the money had been delayed in the international banking system for so long.

But he added that when the company entered the deal with Chinese company APEC, it did not appreciate the difficulties involved in moving money from Chinese entities through banking systems to here.

Speaking at the AGM today, Mr O'Reilly said that while such a scenario was slightly incredulous for us in the west, these type of delays are common in the east.

He added that APEC is strongly representing to the Irish oil exploration firm that the funds will be received by the new backstop date of September 30.

The Providence Resources boss said his company has seen evidence of the funds from APEC's own financiers flowing towards its bank account and it is in a bank en route to here.

Mr O’Reilly added that even if APEC had provided the cash last autumn it would not have been used before now because of the delay the company had experienced in securing state consent for a site survey of the Barryroe site off the Cork coast.

He said the company has already explored a number of legal remedies that might be open to it if the funds do not arrive as promised by the end of the month

The group of new investors in Petrel are nominating two directors. They bring significant financial and hydrocarbon experience in the MENA region, and may inject additional capital and projects on agreed terms.

NT to buy!

All caused by Brexit nonsense!

Self inflicted harm to UK by the ignorant folks who can't see that we were fine and in an exclusive club before they want to out!

Last deadline:
Ceo knows more than the rest of us

Ceo has put his job on the line
Ceo speaks to Apec everyday
Ceo told journalist that funds are coming and to ask him again next week
Ceo has seen the evidence of transfer!

What's another week when we've been waiting 12 weeks!

https://finance.yahoo.com/quote/PZQA.IR?.tsrc=applewf&guccounter=1

PZQA.IR - Providence Resources P.l.c.
Irish - Irish Delayed Price. Currency in EUR
0.0778
+0.0148 (+23.49%)

https://finance.yahoo.com/quote/PZQA.IR?.tsrc=applewf&guccounter=1

PZQA.IR - Providence Resources P.l.c.
Irish - Irish Delayed Price. Currency in EUR
0.0778
+0.0148 (+23.49%)

"The Providence Resources boss said his company has seen evidence of the funds from APEC's own financiers flowing towards its bank account and it is in a bank en route to here."

Tony O’Reilly jnr, the boss of oil and gas explorer Providence Resources, has said his role as chief executive will be come up for discussion if funds promised by Chinese investors don’t materialise before September 30th.

Speaking to journalists after Providence’s annual general meeting, Mr O’Reilly noted that he had confidence that the backers – Apec – had transferred the $9 million (€8.14 billion) but that it was stuck in transfer with HSBC. As such, Providence has set September 30th as the date for receipt of the funds.

Asked whether he’ll consider his position after September 30th, Mr O’Reilly said: “Everything will be discussed. I’m not going to put up flags and say exactly what I’m going to do. We’ll just see.”

Bet you Peter Hamilton will be asking O'Reilly on Thursday 26th about his question from last week!
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Peter Hamilton
Updated: Thu, Sep 12, 2019, 07:59

However, Providence revealed in early June that it had not received the initial payment from Apec. A series of subsequent deadlines for receipt of the funds have been missed, with the latest running out on September 9th. The final deadline has been set as September 30th.

Asked whether the company has been messed around by Apec, Mr O’Reilly said: “I don’t think we have. Ask me that in two weeks.”
https://www.irishtimes.com/business/energy-and-resources/o-reilly-leadership-of-providence-in-balance-if-funds-not-received-1.4015902?mode=amp