SIENTRA launches New Miradry fresh protocol(axillary)

miraDry and other new laser, microwave, radiofrequency and ultrasound based treatments (SweatX, Ultherapy, PrecisionTx).
sinx
Posts: 18
Joined: Sun Nov 22, 2015 4:28 pm

SIENTRA launches New Miradry fresh protocol(axillary)

Postby sinx » Tue Feb 20, 2018 8:40 pm

https://globenewswire.com/news-release/ ... eting.html

Hope we'll be getting an update on the new miradry device for hands soon...

chuck90
Posts: 15
Joined: Tue Jun 20, 2017 9:26 am

Re: SIENTRA launches New Miradry fresh protocol(axillary)

Postby chuck90 » Sat Feb 24, 2018 7:51 am

Fingers crossed you are right, since. Unfortunately, I looked at the FDA 510k filing site to see if there had been any submitted for the new hand piece that MiraDry has been telling us is in the works and I’m not seeing anything. I believe that once a pre-market 510k submission is filed it can take a few months to get a decision. So, you can certainly keep checking back on the 510k site to see if there are new submissions, but right now I’m not seeing one. I think we all still need to continue to contact miradry to keep this top of mind for them. Thanks!!

https://google2.fda.gov/search?q=miradr ... 1&filter=1

chuck90
Posts: 15
Joined: Tue Jun 20, 2017 9:26 am

Re: SIENTRA launches New Miradry fresh protocol(axillary)

Postby chuck90 » Fri Mar 02, 2018 6:28 pm

Latest response from miraDry...

Thank you for your interest in miraDry.
miraDry is approved for the treatment of primary axillary [underarm] hyperhidrosis, and may not be used on other parts of the body.
While we continue to evaluate other treatment indications for the miraDry technology, we are unable to provide more information at this time.
There are not currently active palmar clinical trials, please check back with us toward the end of the years.

Best Wishes,
Info at miraDry



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