Medtronic Shares Surge on FDA Approvals as $670M Trading Volume Ranks 155th

On September 2, 2025, Medtronic (MDT) saw a 0.56% rise in share price, with a trading volume of $0.67 billion, a 39.35% increase from the previous day, ranking it 155th in market activity. The company announced two pivotal U.S. Food and Drug Administration (FDA) approvals for its MiniMed™ 780G system, which could drive long-term growth and market expansion.

The FDA cleared the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with Abbott’s Instinct sensor for type 1 diabetes. This integration, combined with the existing MiniMed 780G insulin pump, completes the regulatory pathway for the system. The Instinct sensor, the world’s smallest and thinnest integrated continuous glucose monitor (iCGM), offers 15-day wear time and discreet design. Medtronic and Abbott plan to finalize compliance documentation in the coming weeks, after which commercial availability will begin, prioritizing existing customers through the Innovations Program.

Separately, the MiniMed™ 780G system received FDA approval for use in adults with insulin-requiring type 2 diabetes, marking the first automated insulin delivery (AID) system with Meal Detection™ technology for this population. Clinical trials demonstrated a 0.7% reduction in HbA1c and an 81% Time in Range for participants, while another study showed a 6.9% HbA1c improvement over 90 days. These approvals align with the American Diabetes Association’s Standards of Care, potentially accelerating insurance coverage and adoption among a larger patient base.

These regulatory milestones expand Medtronic’s diabetes ecosystem, enhancing competitive positioning against rivals like Insulet and Tandem. The integration with Abbott’s sensor technology strengthens interoperability and user experience, while the type 2 diabetes expansion taps into a significantly larger market. Analysts note that the system’s clinical efficacy, coupled with streamlined regulatory pathways, could bolster investor confidence and justify the recent share price momentum.