Israel-based DreaMed scored another FDA clearance, expanding the availability of its AI-supported diabetes care platform to Type 2 patients.
The Advisor Pro Al Clinical Decision Support System helps healthcare providers manage the insulin needs of patients who use insulin pumps or injections and monitor their glucose levels using a continuous glucose monitor and/or blood glucose meters.
The Advisor Pro system had been previously cleared for Type 1 diabetes patients. This is DreMed’s fourth FDA nod, including a de novo approval for the Advisor Pro in 2018.
”Chronic diseases require constant care by experts. DreaMed has done significant clinical research to achieve a strong AI-based clinical-decision-support system that has just received the necessary FDA clearance,” Prof. Moshe Phillip, DreaMed’s chief science officer, said in a statement.
“DreaMed Advisor Pro greatly expands the access to the much-needed expert-level care to millions of people. We are proud of this achievement and committed to work hard on its expansion to additional capabilities and treatment methods.”
WHY IT MATTERS
In 2018, 26.9 million people of all ages – a little more than 8% of the U.S. population – had diagnosed diabetes, according to the Centers for Disease Control and Prevention. Around 90% to 95% of diabetes cases are Type 2.
DreaMed pitches its system as a way to provide endocrinologist-level care to more diabetes patients.
“DreaMed empowers the medical staff to treat significantly more patients by providing access to expert endocrinological advice in primary care settings. We can potentially help avoid thousands of unnecessary hospitalizations and medical complications for the community of people with diabetes and change the overall standards of care in this sector,” founder and CEO Eran Atlas said in a statement.
“The FDA clearance puts us on a path to help millions of people with diabetes, and our next step is to develop and extend our solution to cover all injectable or oral medications for diabetes.”
THE LARGER TREND
Diabetes management is a growing field in digital health. Last month, digital chronic care company Welldoc received its ninth FDA 510(k) clearance for its diabetes management platform BlueStar.
Also last month, virtual clinic 9am.health launched to provide online prescriptions, home medication-delivery, virtual care teams and at-home lab tests to people with prediabetes or Type 2 diabetes.
Hybrid healthcare provider Carbon Health, which announced another acquisition this week, moved into the diabetes-care space in June with its purchase of Steady Health.
In March, diabetes-management startup Glooko scooped up $30 million in Series D funding.