DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software.
The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type I diabetes.
Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.
You can hear her story and more when you register for DeviceTalks Boston, October 8-10.
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