Del Mar, California--(Newsfile Corp. - February 26, 2025) - American Diversified Holdings Corporation (OTC Pink: ADHC) announced today that GlucoGuard has filed an application with the FDA seeking to be designated as a Breakthrough Device.
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 the FDA's commitment to device innovation and protecting the public health.
"We have received initial feedback back from the FDA indicating the application is qualified for review, we expect to hear back with comments from the reviewer in the near future and are optimistic that the GlucoGuard technology presents a compelling case for approval," commented the GlucoGuard team.
This FDA application combined with the recent announcement regarding Continuous Glucose Monitoring (CGM) with development partner Dexcomm has moved the development of this technology along rapidly. More negotiations with Investment Partners are in place and shareholders will be informed in the near future.
See the below link for more information
Breakthrough Devices Program | FDA
About IMD Solutions, Inc. IMD Solutions, Inc. is a Nevada-based medical device company developing GlucoGuard, a patent-pending nocturnal glucose monitoring and delivery system for diabetic patients. The system helps prevent the dangerous effects of low blood sugar during sleep, including the potentially fatal "Death in Bed" phenomenon. Collaborating with a leading U.S. research university, a prominent biomedical engineering firm, and a major CGM company, IMD Solutions is at the forefront of diabetes management technology.
For more information, visit: www.GlucoGuardSleep.com.
Contact: Phone: 817-525-0057
Email: info@GlucoGuardSleep.com
About AMERICAN DIVERSIFIED HOLDINGS CORPORATION
www.UniversalWellnessAI.com
www.UniversalWellnessShop.com
John Cacchioli, CEO
American Diversified Holdings Corporation
Telephone: (212) 537-5900
Email: JC@American-Diversified.com
Social Media:
TWITTER: @ADHCManagement
This Twitter page is the only official Twitter page for ADHC.
SAFE HARBOR FORWARD-LOOKING STATEMENTS: This press release may contain forward-looking statements that are based on current expectations, forecasts, and assumptions that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected, including statements related to the amount and timing of expected revenues related to our financial performance, expected revenue, contracts, and future growth for upcoming quarterly and annual periods. These risks and uncertainties are further defined in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC) and on the OTC Disclosure & News Service (OTCDNS). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in our filings with the SEC and/or OTCDNS. Among other matters, the Company may not be able to sustain growth or achieve profitability based upon many factors including but not limited to the risk that we will not be able to find and secure construction contracts and the necessary assets that will enable us to become profitable. Reference is hereby made to cautionary statements set forth in the Company's most recent SEC and/or OTCDNS filings. We have incurred and will continue to incur significant expenses in our development stage, noting that there is no assurance that we will generate enough revenues to offset those costs in both the near and long term. New lines of business in the construction industry may expose us to additional legal and regulatory costs and unknown exposure(s), the impact of which cannot be predicted at this time. Words such as "estimate," "project," "predict," "will," "would," "should," "could," "may," "might," "anticipate," "plan," "intend," "believe," "expect," "aim," "goal," "target," "objective," "likely" or similar expressions that convey the prospective nature of events or outcomes generally indicate forward-looking statements. You should not place undue reliance on these forward-looking statements, which speak only as of this press release. Unless legally required, we undertake no obligation to update, modify or withdraw any forward-looking statements, because of new information, future events or otherwise.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/242212
SOURCE: American Diversified Holdings Corporation
