going for a italian castle....
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FDA mail:
Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical device industry and reduce private costs and expenditures required to comply with federal regulation, the FDA is exempting or partially exempting (exempting with limitations) these devices from the premarket notification [510(k)] requirements. The list of exempted device types is final upon publication. This announcement follows streamlined procedures established by the 21st Century Cures Act.
On March 14, 2017, the FDA posted in the Federal Register a list of class II device types that it proposed to exempt. While the public comment period closed after 60 days on May 15, 2017, interested persons may submit additional comments to Bryce Bennett (Gregory.Bennett@fda.hhs.gov) at any time.
The FDA periodically exempts from premarket notification review such medical device types when appropriate. On April 13, 2017, the Agency posted a list of 71 class I device types that the FDA exempted or partially exempted from premarket notification [510(k)].
Medical device types that are exempt from 510(k) are not exempt from other regulatory controls, unless such exemption is explicitly provided by order or regulation. All medical devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have current establishment registration and device listing with the FDA.
Additional Information for Sponsors of 510(k)s for Device Types that are Now Exempt or Exempt with Limitations:
Sponsors with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should contact the 510(k) lead reviewer to discuss if their device falls within the general limitations of exemption per 21 CFR XXX.9 (i.e., the device is exempt and the sponsor may choose to withdraw their submission or receive a “device is exempt” decision letter) or exceeds the limitations (i.e., review of the 510(k) should continue).
Sponsors with existing 510(k)s for device types that are now considered exempt are not required to take any action at this time.
Sponsors who currently hold 510(k)s for device types that are partially exempt from premarket requirements must make a determination whether their specific devices are exempt or non-exempt. Partial exemption limitations can be found in table 1 of the Federal Register Notice.
The FDA has assigned new product codes to the device types that are now exempt, subject to the partial limitations, in order to separate these devices from those that do not fall within the partial exemption limitation under the existing product code. Today’s Federal Register Notice lists the new (exempt) procodes.
Sponsors should review their registration and listing information to assess if they should list their devices using the original classification product code, which requires premarket notification, or if they should use the new classification product code that is now 510(k) exempt.
If a sponsor chooses to list its device using a new procode, it should deactivate the existing listing and, create a new one, including the proprietary or brand names under which it is marketed.
If a sponsor is marketing multiple devices that include products under both the original product code and the new product code, they should leave their existing listings under the old product code active, as appropriate, and create a new listing under the new product code.
Importers and exporters of medical devices should use the same product code under which the device is listed.
Device labelers that have submitted device identifiers DI records to the Global Unique Device Identification Database (GUDID) for devices types that are now exempt or partially exempt from premarket notification requirements should be aware that changes may need to be made to these record(s) in the future.
The FDA is working on updates to the GUDID to make it easier to make changes to device identifier records. We will notify affected labelers when the database updates have been completed and provide further information and instructions.
For additional information, contact DICE@fda.hhs.gov.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health
I hope you don't suggest that it's all fake what Cyrcadia is doing, is making! That women are cheated by machines. In our medical world we have to rely on what we have made, have tested and experienced. EVERY test we make on people the sensitivity nor specificity is 100%. There is always a chance that we do not detect for instance in this case breastcancer! Despite all test and medical devices. There is always a chance we think to detect something but eventually it is not (lots of biopsies that were unnecessary). That is what this is all about. The ITBRA of Cyrcadia has already proven to detect breastcancer earlier and is more sensitive than x-rays or echo's. Also the digital version seems to outrun the conventional techniques (in the preliminary results). Especially in women with dense breasts. So on all your questions I can say YES. I have very much idea. I know how the Food and drugs Administration works, I know what new devices must prove.
So I think it is strange to speak about women trusting a machine, high efficiency or responsibility. I hope you know what you are talking about? Otherwise you could disqualify women with breastcancer and the hopes of women with genetic predisposition and dense breasts.
Global and United States' healthcare artificial intelligence market forecast to 2022 published by leading research firm.
Look at Cyrcadia (=LLBO) between those big companies!!
The major players in global and United States Healthcare Artificial Intelligence market, including IBM Watson Health, AiCure, Atomwise, Cyrcadia Health, Lifegraph, Modernizing Medicine, Sensely, Zebra Medical Vision, Sophia Genetics, iCarbonX, Welltok, Butterfly Network, APIXIO, Pathway Genomics, Enlitic, Insilico Medicine.
https://www.whatech.com/market-research/medical/348507-global-and-united-states-healthcare-artificial-intelligence-market-forecast-to-2022-published-by-leading-research-firm
Soooooo true!!! JACKPOT!!!
LLBO will follow the price of Cyrcadia ($1= 0.0040 -> $5= 0.02) that is the most important!!!
"Cyrcadia is expecting to be cleared for the FDA market entry
before the year is over
That is one of the value adds that will raise the price of Cyrcadia $2.50 -$5.00 also"
Yes the conclusion is that we simply aren't informed enough. There's were our guesses begin. So we wait for an announcement or ask ourselves?
Conclusion is also that WE PROGRESS!! This train is running and eventually LLBO will have to follow wether we want to or not. :)
Still it says: Cyrcadia, Inc. expects to apply for FDA Clearance and a CE Mark, (to market in the European Union and Asian markets), with anticipation of launching its technology to market possibly in late 2017 or early 2018.
I read this as they need this and CE for Asia and Europe: in the sheet "global launch sequence 2018" at Asia/Europe they state this:
CE/FDA Regulatory Process
- Defined Time line to allow launch in FDA regulated countries H12018, CE countries H2 2018
At North America:
FDA Regulatory Clearance
- Cyrcadia Predicate 510K Class II exists now
- Sales can begin in US and other FDA guided countries H2 2017
Maybe they only needed the older one because of changed and less severe regulations of the FDA lately. Otherwise they shouldn't state "Cyrcadia Predicate 510K class II exist now" !!!
Also stating immediately: "Sales can begin IN US AND OTHER FDA GUIDED COUNTRIES H2 2017"
Sometimes you have to dilute to get money for further development.
Stil the O/S is nothing in compare to other companies.
1,6B market in US only!
FDA is meant for the safety of patients. It's not likely that the FDA gives clearance on a device without knowing what software goes with it. A clearance for software later on would not be very careful. That would be very unwise and not thoroughly. I can't imagine those two are revised separately by an organization like the Food and Drug Administration.....
That's how I read this too.... (!!)
Some shortsighted people have only one word in their vocabulary: scam....
Well there are lots of scam OTC, but some are real companies with real products..... Not for flippers, but long term. Pps intraday is not important....
Go RCHA, FRZ•T, LLB•O
Due to its focus on precision medical initiatives, Cyrcadia has been requested by The Stanford Medicine X program to participate in a randomized trial to demonstrate the increased value of personalized healthcare assessment, versus hospital-based treatment in a randomized population. That trial request has been expanded now with and through Stanford University to key institutions in Asia including Japan, South Korea, India, and Australia, where mass populations of women either cannot access healthcare, or social, economic, or religious morays keep them from exposing themselves in the presence of a physician.
https://medicinex.stanford.edu/master-homepage/
Everyone Included™ is a framework for healthcare innovation, implementation and transformation based on principles of mutual respect and inclusivity. It is the culmination of six years of co-creation with patients, caregivers, providers, technologists, and researchers at Stanford Medicine X that has resulted in a series of design and leadership principles intended to drive collaborative healthcare innovation efforts. Our work has been field tested and iteratively improved over the past six years at our Stanford programs and convenings worldwide.
FDA CLEARANCE Cyrcadia predicate 510K class II EXISTS NOW!!!
MEGA global launch for general screening of population. Multi site pilot launch! The results will catalyze the enrollment of the ITBra further....
Medicine X is a 3-day conference that serves as catalyst for new ideas about the future of medicine and health care. The initiative explores how emerging technologies will advance the practice of medicine, improve health, and empower patients to be active participants in their own care.
Also sales US H2 2017
This is the presentation of Rob Royea in Hong Kong!
So what we are all waiting for already exists..... ironic.
FDA clearance class II !!!!
Did I see that right?
And H2 2017 sales in US....
(Thanks Change for sharing)
You understand it!! Not interested in the intraday pps, not interested in volume, not interested in all those negative interpretations. Just hold long and be confident. If one is not, I ask myself why invest in this and try to interpreter everything negative.
WE HOLD AND WIN!
Well YOU are still interested! That's my indicator..... This stock is still alive, a little bit sleepy but going to explode.
I'm also not mentioned! And pears also not, and Change also not and intexp also not and mead also not.....
You don't understand what this article tries to say. The disease is the problem, the medicine that is being processed right now by Rich is the solution!
I'm a doctor in the Netherlands and know that Medical cannabis is up coming in oncology. So it is not strange this company will try to get a piece of that pie. If they succeed, with all other activities in oncology and Parkinson this ticker will shoot! I personally think they can sell those patents or medicine to the big pharma's or can get bought out.
Because of their latest deal and prospectus this should be at 0,01 at least right now.
GM Chaka. We have the most patience in both zip code changers....
Added..... 20M and patience
Buy-sell-buy-sell-buy-sell ecc so 8 times os
No bounce eod..... damage-control and selling last 20 min
Pre market boring. 2.28-2.40
Historical Trial Results
Our iTBra technology was successfully tested with over 200 patients, with a trial originating at The Ohio State University. Cyrcadia Health solution demonstrated an 87% correlation to a verified, clinical diagnosis of breast cancer including with those patients with dense breast tissue. The Ohio State University, along with El Camino Hospital, Mountain View, CA are now undertaking a final 173 patient trial with Cyrcadia.
Core Science
Cyrcadia Health’s technology detects normal circadian cellular baselines, as well as those abnormal patterns associated with the state of cancer. Earliest patient study results indicate that Cyrcadia Health’s accuracy equates to mammography in the identification of cancer, but has improved results with patients that have been diagnosed as having dense tissue.
Current Clinical Trials
Cyrcadia Health intends to show equal to improved results to mammography in the general population with improved results over today’s “gold standards” in the dense tissue population, which entails over 40% of all women. We are also targeting the 70% population of women who have biopsies on non-cancerous tissue due to mammographic referral. Our comfortable, non-compressive and non-irradiative approach will help to populate a global core library on phenotype/genotype, and demographic variables contributing to the state of breast cancer on a worldwide basis.
No this is recent news
I would sign for 0.05 but would not complain if this goes to 0.10.....??
Your "seems" says it all.....
What I tried to state here is that all kind of negative "news" here is not proven and very thin..... not going to make me believe less.
Not proven that it is active is not the same as proven not active.....
GLTYA
Pps LLBO to come: A summary of what we stated and proved:
Actually that's quite simple. The pps Cyrcadia is related to the pps LLBO.
1$ Cyrcadia (actual pps) is equal to 0.0040 LLBO
after FDA Cyrcadia will raise there pps to $ 2,50-5
That makes pps LLBO 0,01-0,02
After that more steps to come.... thus higher pps......
My estimation is 0,08 at buyout but that is jmho....
The permit is UNTIL now inactive....
Look at the date of your proof: it says date 01/22/2010 !!
Their goal is to reopen it with the right people and knowledge....
At the end of this month they would update....
But what do you have as evidence of all that you stated? Now these are only words....
Very well done. This is the REAL story.
forget Jason: he is out.....
Wes Johnson :
Wes Johnson has over 15 years of experience in the coal industry at varying levels. His expertise in strip mining, terminal management and heavy equipment provides the practical knowledge and leadership that First Columbia Gold Corp. will need to achieve success in this new venture.
“I am excited to lead First Columbia in this new direction and to kick off operations with this first coal lease. This is an exciting time in the market and I believe that my experience and connections within the industry will be a valuable asset to First Columbia Gold Corp.,” stated Johnson.
About Wes Johnson:
Highly motivated and energetic team leader with experience in underground mining. Holds an advanced degree in Mine Engineering with a focus on geomechanics. Has successfully pioneered projects in underground ground support/rehab, underground electronic blasting, mine design software implementation, and geomechanical instrumentation.
Past experience includes project management, rock mechanics, computer modeling, and engineering.
Specialties: Underground Rock Mechanics
Project Management
Contract Management
Mine Planning
Eng. Management
VA Underground Foreman
VA Underground Blaster
3D mapping software (i.e. Minesight, Vulcan)
AutoCAD mine design
Carlson - Survey and design