Story thread · 2 reports / 2 sources

FDA Clears DreaMed MODI: First CGM-Driven Insulin Dose Optimization App for Type 2 Injection Therapy

hitconsultant.net · 10h

What You Should Know The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MODI, a prescription software-as-a-medical-device (SaMD) application developed by DreaMed Diabetes Ltd. that calculates and delivers autonomous insulin dose titration recommendations directly to patients. The clearance establishes a new digital therapeutics category by bringing automated algorithmic dose optimization to the ... Read More

First report: DreaMed Wins FDA Clearance for CGM-Driven Insulin Automation Tool for Both Type 2 Injection Regimens — medcitynews.com, 2d

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