FooBarAndGrill
5 years ago
So, I'll be watching this ticker. It sounds as if they compared the second generation device to their existing first generation device. "We are pleased, but not surprised by the safety testing results of our RAP device. The safety of our second generation device mirrors that of our first, and these results reinforce this. We look forward to submitting this safety data in early 2020, simultaneous with the Special 510k filing of our second generation RAP device. This step is an important one in our plans to commercialize the device being launched for tattoo removal to a select and limited number of dermatologists in mid-2020."510(k) Premarket Notification. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.
Almost two out of three 510(k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests.
TFMG
5 years ago
$SOLY Soliton Inc continue to rally higher, more expected.
June has been a fantastic month for investors in NASDAQ:SOLY which has released numerous announcements of a very positive nature regarding pipeline products with new FDA clearance.
As of this morning it has been announced that there will be a conference call today to update investors, this could move the stock considerably.
https://www.marketwatch.com/press-releas...
COMPANY PROFILE
Soliton , Inc. is a medical development company. It develops healthcare technological devices for medical and cosmetic treatments. The firm's devices generate planar acoustic waves or shock waves in cosmetic surgical procedures, aesthetic surgical procedures, and dermatology procedures for treatments. The company was founded by Walter V. Klemp & Christopher Capelli and is headquartered in Houston, TX .
RichardSawars
5 years ago
Soliton Announces Significant Discovery of Acoustic Subcision for Treatment of Cellulite
Source: PR Newswire (US)
HOUSTON, June 4, 2019 /PRNewswire/ -- Soliton, Inc., (NASDAQ: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced results of preclinical studies of the use of a new version of its acoustic pulse technology which reveal its RAP device appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite.
stockstalk09
5 years ago
I was the first one to do a post yesterday on this stock,on how the fools at seeking alpha now look like such a rag publication, when they let some moron print a very negative story on this company how they were not close to getting the FDA approval, and all the dumb ass seeking trash shorter's got burned to a crisp, I was laughing yesterday at $13.75 where I sold half, but today after selling more at $28.00, my whole body hurts from laughing and jumping up and down from bitch smacking shorts and the too soon flippers have gotten shoved in their faces today.