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Axonics® Announces U.S. Food & Drug Administration Approves Use of Full-Body MRI for Pivotal Study Patients

)--Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable sacral neuromodulation (“SNM”) devices for the treatment of  urinary and bowel dysfunction , today announced the U.S. Food & Drug Administration (“FDA”) approved the use of full-body magnetic resonance imaging (“MRI”) using 1.5 Tesla MRI scanners for clinical study patients implanted with the Axonics System.

The approval was a result of a supplement filed by Axonics with the FDA under the Investigational Device Exemption (“IDE”) regarding the Company’s ARTISAN-SNM 129-patient pivotal clinical study. The FDA concluded that Axonics provided sufficient data to support full-body MRIs.

Raymond W. Cohen, CEO of Axonics, commented, “Allowing full-body MRI scans for our clinical study patients means that none will have to undergo an explant of their neurostimulator device should they require an MRI. We view this as a very positive step by the FDA that underscores the quality of data that Axonics has submitted to the agency. Given this approval, we are confident that this capability will be included as part of the Axonics SNM System premarket approval (“PMA”) approval, which is anticipated in the second half of 2019.”

Grand mum experiencing bladder and kidney infections - TOO OFTEN....?

Her age: 62
Weight: 67

BP: normal
Sugar level: normal
Cholesterol: under control

Daily supplements:
Calcium and anti-oxidants
Phyto soya for HRT (half dose)

The problem:


Many times bladder, urinary tract, and kidney infections result from not drinking enough water to flush out bacteria, especially in older people who are not very mobile. Infections that start in the urethra can spread to the kidneys. When urine sits in


Many times bladder, urinary tract, and kidney infections result from not drinking enough water to flush out bacteria, especially in older people who are not very mobile. Infections that start in the urethra can spread to the kidneys. When urine sits in


Hi there. I'm nearing 50 and am learning that increased bladder and kidney infections is a fact of life for aging women. Oh Joy!

She may wish to drink more real cranberry juice (not punch) - it helps flush out toxins. It's also very important

Do I have a bladder infection?

I pee way too often. I have to squeeze to make sure I can get it all out, and sometimes when I sit back down afterwards, more pee comes out. During school I go in between almost every class, but during the class I just peed before I feel like I need to


Doesn't sound like it..usually a urinary tract infection involves stinging/burning during urination, frequent urination, dark and urine with a strong or foul odor..the only symptom you said was frequent urination which alone is not a sign of urinary tract


Doesn't sound like it..usually a urinary tract infection involves stinging/burning during urination, frequent urination, dark and urine with a strong or foul odor..the only symptom you said was frequent urination which alone is not a sign of urinary tract