UArizona Startup NeuTherapeutics Wins $2.5M Grant to Fund Clinical Trial of PhytoSERM, a Natural Approach to Menopausal Hot Flashes

TUCSON, Ariz. – NeuTherapeutics, a Tucson startup founded to commercialize University of Arizona technology has received a $2.5M Small Business Innovation Research (SBIR) grant from  the National Institutes of Health/ National Institute on Aging (NIA) to conduct a Phase 2 clinical trial to evaluate the impact of a new dietary supplement, PhytoSERM, on menopausal hot flashes in women.Continue reading

GT Medical Technologies, Inc.’ GammaTile® Therapy Awarded 2023 Most Promising New Product of the Year by The Phoenix: The Medical Device and Diagnostic Conference for Chief Executive Officers

Oct. 13, 2023 /PRNewswire/ — GT Medical Technologies, Inc. a medical device company dedicated to improving the lives of patients with brain tumors, today announced that its FDA-cleared GammaTile® Therapy was awarded the 2023 Most Promising New Product of the Year by The Phoenix: The Medical Device and Diagnostic Conference for Chief Executive Officers. Continue reading

Barrow Neurological Institute receives $16.7 million NIH award to help coordinate new national ALS research consortium

(PHOENIX – Oct. 5, 2023) –  Barrow Neurological Institute has received a large award from the National Institutes of Health (NIH) to help create and lead a groundbreaking and transformative national amyotrophic lateral sclerosis (ALS) clinical research consortium. The award is the largest Barrow has ever received from the NIH with a first year budget of $16.7 million.Continue reading

AdvaMed Launches New Digital Health Tech Division, Appoints Board Members

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, announced the formation of AdvaMed Digital Health Tech, a new division within the organization that represents digital medical technology companies and promotes the critical role of data and digital medtech in transforming health care. The group, which is led by Shaye Mandle, acts as a thought leader and convener for the industry and focuses on four core policy areas: regulation, payment and health care delivery, data stewardship and privacy, and cybersecurity.

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Special Report: FDA’s proposed rule to bring LDTs into the fold

After bringing up the topic many times over the past two decades, the FDA has finally done it: They’ve issued a proposed rule that would eliminate the agency’s enforcement discretion over laboratory-developed tests (LDTs), integrating LDTs into the FDA’s oversight over a period of four years. This issue has been top of mind for the FDA and most everyone in the diagnostics ecosystem for many years. The change has the potential to be a very big deal. Whether for good or bad depends on your viewpoint.Continue reading