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 85% of insulin users who rely on daily injections rather than continuous subcutaneous insulin infusion (CSII) pumps.
- The application is specifically indicated for adults aged 18 and older with type 2 diabetes who utilize injectable long-acting (basal) insulin, with or without prandial rapid-acting insulin (multiple daily injections / MDI).
Overcoming the “85% Deficit”: Direct-to-Patient Injection Automation
Approximately 85% of all insulin users rely on subcutaneous injections rather than wearable electromechanical pumps. MODI is engineered to bridge that technological divide:
- Dual-Regimen Coverage: Unlike early digital titration pilots limited strictly to once-daily basal insulin, MODI is cleared for adults aged 18 and older with type 2 diabetes using long-acting (basal) insulin alone or in combination with rapid-acting (bolus) mealtime injections—supporting complex multiple daily injection (MDI) regimens.
- Autonomous Dose Generation: The platform continuously translates streaming CGM trend curves and patient-logged insulin injection data into specific, actionable unit adjustments delivered through the mobile interface.
- Zero Physician-in-the-Loop Bottleneck: Crucially, MODI does not require clinicians to configure rigid upfront dosing parameters or manually approve each incremental titration. The algorithm adjusts therapy dynamically between office visits, removing the administrative burden that overwhelms primary care and endocrinology inboxes.
Corporate Backing and Clinical Context
Spun out in 2014 from research initiatives at the Schneider Children’s Medical Center (part of Clalit Health Services), DreaMed has developed clinical decision support tools backed by more than $35.5M in total capital (comprising $12.5M in equity from strategic investors like Medtronic, eHealth Ventures, SIBF, and OurCrowd, alongside $23M in non-dilutive research grants).
The application is named in memory of Modi (Mordechai) Amir, a technology professional from Kibbutz Kfar Aza who was killed on October 7. DreaMed connected with the Amir family through the Next October initiative, securing the family’s blessing to honor his legacy through the official FDA registration.
