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What is the Breakthrough Devices Program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects our commitment to device innovation and protecting the public health.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
What are the benefits of the Breakthrough Devices Program?
The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
Almost a decade into the FDA’s Breakthrough Devices Program (previously the Expedited Access Pathway) and there have been 839 Breakthrough Device designations granted, as of June 30 this year. While that seems a significant number, the FDA also reports that only 81 marketing authorizations have been approved.
Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation
Published: Dec 20, 2023
Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
BDD in hand , next is the IDE submission and approval followed by human trials treating thyroid cancer at the Mayo Clinic.
Things will be moving fast for this company .
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
Everyone is ignoring him due to that and lack of credibility,,,
I wouldn't give him the platform to responding to your post with more lies and FUD.
Great posts chereb . Thanks for all of the information
More than one FUDster on the board
Ignore x3
Just a reminder to ignore the many posts that we will see in the morning from the FUDster
Once they've received the IDE, the Mayo clinic will be ready to start human trials for thyroid cancer. Results from that trial won't take very long. Things can and will move very fast imo.
Agree Chereb. He was granted special permission by the Mayo clinic to join that advisory board. I'm sure they did their DD on the company.
Silence can be golden.
Our next update may be a PR that will send the share price into the stratosphere.
Hang on to those shares.
Loving the board today .
There’s lots to discuss besides FUD
2024 is going to be a very exciting year for RDGL and it’s shareholders.
Hope they’re on board .
It would sure clean up things here .
Agree ,
Hopefully nobody will respond to him and his 2 buddies . Take away his platform and let him talk to himself .
We are at a pivotal point in this company’s history and they know it . New investors will be checking out this board and they know it .
Don’t fall into the trap and respond to his bs/FUD
He/she will still post bs/fud but it’ll be limited and not the topic of discussion on a daily basis . He/she knows their posts are bs but that doesn’t matter. What matters to them is that it is discussed and brought up .
Please ignore the three tenors , especially the ring leader , SC8
Can we all finally ignore SC8 and not respond to his BS/FUD?
Close
Disgruntled ex employee.
Must be getting close .
The 3 tenors are back in concert .
IDE submission followed by approval and clinical trials right after that .
Exciting times for the company and it’s true shareholders.
I think I'll listen to the company over a disgruntled ex employee posting FUD on a daily basis.
Lights will be coming on soon and the FUDster will disappear.
Ignore them , unless you like seeing more of their FUD posts
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.
The same FUD over and over until he’s ignored . Then he talks to himself .
Ignore
Just ignore the FUD posts...
Just try it..
I've been adding as well. I feel this next update is the one we've been waiting for. Sitting at 7 cents ,with the BDD in hand and the IDE about to be submitted, with Mayo ready to initiate human trials. These prices won't last long imo.
They don’t believe the nonsense they write ,,, they’re just getting paid to do a job .
New investors are here and more will be coming . Do we want these FUD posts to be the topic here ? One poster does .
Certain posters repeat themselves . It’s their way of spreading their FUD .
Quit responding and their platform is diminished.
and spreading his FUD bs. That's all he cares about,
Best to ignore
Looking forward to the next quarterly update that could drop this week or next.
The same FUD posts from a certain poster are sounding a bit desperate.
Those here to spread FUD are really reaching this morning.
We are close!
Next quarterly update can drop at any moment and it may be the one we've been waiting for.
BDD in hand and IDE about to be submitted,
We're way under the radar at the moment imo,, but not for long..
Same. This may be the update we’ve been waiting for . We’re close to the IDE submission . Very exciting times for RDGL and it’s true shareholders .
Could be this week or next . Quarterly updates in the past have generally been in the first couple weeks of the quarter .
See post #169139 regarding patents .
Someone on this board is here to spread FUD . That is their job 24/7
Ignore the nonsense .
I agree 100%.
We have the BDD in hand and are about to submit the IDE ,with careful hand holding by the FDA every step of the way, which greatly increases the likelihood of an approval.
This will move fast and surprise many and we have a front row seat.
Nice post kayak.
Things may be happening real fast in 2024!
Happy Holidays to our loyal shareholders and supporters across the globe. As we approach certain milestones we’d like to share our appreciation to each and every one of you. We are working on posting more updates and thank you for your patience.
— Vivos Inc. (@VivosIncUSA) December 28, 2023
Positive 8k imo.
Good things are happening.
Gearing up for a fantastic start of 2024