DreaMed receives 5th FDA Clearance

TEL AVIV, Israel: DreaMed Diabetes LTD. ("DreaMed" or the "Company"), developer of the endo.digital Clinical Decision Support System announced today that it has received its 5th U.S Food and Drug Administration (FDA) clearance that expands the scope of AI enhanced treatment recommendations to patients on fixed meal insulin regimens. endo.digital is the first decision support system that has been cleared to assist healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using continuous glucose monitor and/or blood glucose meters.
Prof. Moshe Phillip, DreaMed's Chief Science Officer and the Director of the Endocrinology and Diabetes Institute at Schneider Children's Medical Center in Israel commented, "As the shortage of diabetes experts persists globally, we continue to expand the use cases where we can unleash the power of AI to support patients and providers across all care settings. We are proud of our achievement to use AI to transform patient data into expert level treatment recommendations for yet another use case that meets FDA requirements."
Eran Atlas, DreaMed's Founder & CEO commented: "As a company, we are not only expanding the addressable population for which we deliver value to customers, but also reducing the time it takes to get new FDA cleared use cases to market. This most recent FDA clearance for fixed meal regimens required only 4 weeks to complete. This is increasingly critical, as the market needs these solutions. In the U.S. alone, there are over 41,000 adults per endocrinologist1, and more than 50%2 of all people with diabetes that are not well managed due to limited access to proper care.

About dreamed: DreaMed is a software company that uses AI to transform patient data into expert level treatment recommendations. Since partnering with Medtronic to pioneer the world's first artificial pancreas, DreaMed has achieved 5 FDA clearances, and launched endo.digital, a decision support platform that automates the diabetes care pathway from end-to-end. The platform is compatible with most diabetes devices on the market, integrates into the EMR, and is clinically proven4.

For more information visit: https://dreamed.ai

1https://www.aamc.org/what-we-do/mission-areas/health-care/workforce-studies/interactive-data/number-people-active-physician-specialty-2019
2 https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
3 IDF DIABETES ATLAS, 9th edition 2019 (available at: https://www.diabetesatlas.org/en/)
4 Nimri, R., Battelino, T., Laffel, L.M. et al. Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes. Nat Med 26, 1380-1384 (2020). https://doi.org/10.1038/s41591-020-1045-7

DreaMed Diabetes Inc
1650 West End Blvd., Suite 100, St. Louis Park, Minnesota, 55416
USA
Ryan Hovey, General Manager, North America
Marketing@dreamed.ai

Our mission is to unlock and scale medical knowledge so that every person living with diabetes can access personalized, expert-level care when and where it's needed. We strive to achieve this mission by creating software that uses advanced AI and analytics to transform the massive amounts of patient data available into expert-level treatment recommendations, and to do this at a global scale.

Founded in 2014, our company pioneered the first artificial pancreas technology. Since then, DreaMed Diabetes has dedicated itself to developing decision-support tools in the diabetes management field. We are the world's first and only company to receive FDA clearance for a decision support system that utilizes data from CGM/SMBG (continuous glucose monitoring/self-monitoring of blood glucose) and insulin pumps.

Our founders are physicians and engineers. Our products are developed based on real insights from the clinical practice of diabetes specialists, physicians, and clinical researchers from the top diabetes centers worldwide. We prioritize privacy, security, quality, and regulatory compliance, operating under a stringent quality management system and adhering to ISO 27001, GDPR, and HIPAA standards.

This release was published on openPR.