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Circularity Healthcare Named “Company of the Year” – Top 10 Diabetes Care Solution Providers 2018

BREAKING NEW GROUNDS IN Diabetes Care

According to the American Diabetes Association, millions of people around the world live with diabetes or know someone living with diabetes. No type of diabetes is curable yet; however, it is a very treatable disease, and no matter how frightening, annoying, and frustrating it can be, people with diabetes can live long, healthy, and happy lives. Our goal is to provide you the information, tools, and resources to help make that happen. In a recent statistics report from CDC National Diabetes Statistics, diabetes remains the 7th leading cause of death in the United States in 2015, with 79,535 death certificates listing it as the underlying cause of death and a total of 252,806 death certificates listing diabetes as an underlying or contributing cause of death.

With numerous methods on the market for managing and treating diabetes, there is one product that is a cut above the others when it comes to diabetes care–D’OXYVA by Circularity Healthcare. Setting a new paradigm in health science, D’OXYVA is a truly unique technology at its core, a first-of-its-kind biotech solution clinically validated to significantly lower the risk of diabetes and cardiovascular complications.

Circularity Healthcare was recently selected for the list of “Top 10 Diabetes Care Solution Providers of 2018” in the upcoming November Diabetes Care special edition of MedTech Outlook magazine after receiving more than 270 unique nominations from more than 39,000 qualified print and 66,000 qualified digital subscribers. The magazine does not rank the top ten providers; it lists them in alphabetical order on a full page. In addition, the magazine will run a featured article on Circularity and its D’OXYVA product line in the same special edition this November.

The future holds favorable prospects for Circularity Healthcare. They are expecting continued commercial growth with D’OXYVA, with other major announcements to follow shortly in multiple leading media outlets in the US and around the world as Circularity’s global marketing and PR campaign based on years of yet-unpublished highly successful clinical evidence unfolds in the coming weeks and months.

At the end of it all, D’OXYVA is indeed a revolutionary and a much-needed step toward a powerful and safe diabetes care solution that is adding immeasurable value to health outcomes.

December 2018 digital issue of MedTech Outlook: https://www.medicaltechoutlook.com/magazines/December2018/Diabetes_Care/#page=27

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Benefit from D’OXYVA’s IDE status

By virtue of the fact that Institutional Review Boards (IRBs) approved human clinical studies with D’OXYVA® and concluded that it was a Non-Significant Risk (NSR) device, D’OXYVA® has an approved Investigational Device Exemption (IDE). See 21 CFR 812 reference below in section (b) and (1) highlighted in CAPITAL LETTERS.

This means D’OXYVA can be used for any medical purposes under testing (investigations). Doctors can ask their patients if they would like to try and test D’OXYVA® for a certain period of time to see if it helps their condition. First, D’OXYVA should be used as an adjunct application combined with other therapies (no negative interference with other modalities has been reported to date). Typically, patients should test D’OXYVA® for the first time for 6-8 weeks twice a day for the first two weeks and then once a day to achieve best results according to various clinical trial results and user feedback with D’OXYVA® . Severe cases should continue using it twice a day for 4 weeks and then based on progress lower dosing to once a day.

(b) Abbreviated requirements. THE FOLLOWING CATEGORIES OF INVESTIGATIONS ARE CONSIDERED TO HAVE APPROVED APPLICATIONS FOR IDE’S, unless FDA has notified a sponsor under 812.20(a) that approval of an application is required:

(1) AN INVESTIGATION OF A DEVICE OTHER THAN A SIGNIFICANT RISK DEVICE, if the device is not a banned device and the sponsor:

(i) Labels the device in accordance with 812.5;

(ii) OBTAINS IRB APPROVAL OF THE INVESTIGATION AFTER PRESENTING THE REVIEWING IRB WITH A BRIEF EXPLANATION OF WHY THE DEVICE IS NOT A SIGNIFICANT RISK DEVICE, AND MAINTAINS SUCH APPROVAL;

(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator’s care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 56.109(c).

(iv) Complies with the requirements of 812.46 with respect to monitoring investigations;

(v) Maintains the records required under 812.140(b) (4) and (5) and makes the reports required under 812.150(b) (1) through (3) and (5) through (10);

(vi) Ensures that participating investigators maintain the records required by 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and

(vii) Complies with the prohibitions in 812.7 against promotion and other practices.