Medtronic’s MiniMed Go Secures FDA Clearance for Smart MDI System Integrating InPen, Abbott Sensor

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Medtronic Diabetes secured FDA 510(k) clearance for its MiniMed Go™ Smart MDI system integrating the InPen™ smart insulin pen with Abbott’s Instinct sensor for real-time dose and glucose data. The system, cleared for ages 7 and older, offers missed-dose alerts and dose guidance; is slated for U.S. launch this spring.

1. Medtronic Bolsters Acquisition War Chest

At the J.P. Morgan Healthcare Conference in San Francisco, Medtronic executives confirmed the company holds more than $20 billion of available liquidity—comprising cash on hand and undrawn credit facilities—to fund strategic bolt-on and transformational M&A. CEO Geoff Martha highlighted that the balance sheet flexibility stems from disciplined free cash flow generation (over $6 billion in 2025) and a target leverage ratio below 3× net debt/EBITDA. This financial capacity positions Medtronic to pursue companies in high-growth segments such as robotics, digital surgery and next-generation implantables, with management signaling an appetite for deals in the $500 million to $5 billion range over the next 24 months.

2. Precision Neuroscience Partnership Advances Brain–Computer Solutions

Medtronic has entered a co-development agreement with Precision Neuroscience, combining Precision’s Layer 7™ cortical interface technology with Medtronic’s StealthStation™ surgical navigation platform. The integrated system will deliver real-time functional and structural brain mapping in the operating room, reducing intraoperative decision times by up to 30 percent, according to internal projections. Medtronic’s Neuroscience business unit, which generated $2.8 billion in revenue in 2025, expects the collaboration to support a new suite of adaptive therapies and drive double-digit growth in its cranial surgery segment by 2028.

3. FDA Clears MiniMed Go™ Smart MDI System

The U.S. Food and Drug Administration granted 510(k) clearance for Medtronic’s MiniMed Go™ app and integrated smart MDI system, which combines the InPen™ reusable insulin pen with Abbott’s Instinct continuous glucose sensor. Clinical data from 1,852 type 1 diabetes users showed Time in Range improvements from 55.7 percent to 67.2 percent when users responded to more than 75 percent of missed-dose alerts within one hour. The system is cleared for patients aged 7 and older, with pediatric use (ages 2–6) under caregiver supervision. Commercial launch is slated for spring 2026, supporting Medtronic Diabetes’s goal of expanding its non-pump customer base by 25 percent over the next year.

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