On Jan 12, 2026, the FDA approved Medtronic’s MiniMed Go Smart MDI system for injections with their InPen insulin pen.

The FDA has approved a wide range of insulin pens, including prefilled disposable pens, reusable pens, and smart insulin pens, for different insulin types (such as rapid-acting and long-acting) and across multiple age groups.

Recent approvals have focused on smart insulin systems — like Medtronic’s MiniMed Go, which integrates the InPen for detailed dosing data — as well as more affordable options like the GO-PEN, intended to be more accessible.

Many of these devices emphasize dose tracking, reminders, and data sharing with your healthcare team.

Types of FDA-Approved Insulin Pens

Prefilled Disposable Pens
These pens come preloaded with a specific insulin (such as Humalog KwikPen or Apidra SoloStar). They are intended for single-patient use and are approved for various ages and diabetes types.

Reusable Pens
Reusable pens allow users to insert insulin cartridges and often include smart features. A common example is the InPen.

Smart Insulin Pens
These pens connect to smartphone apps via Bluetooth and offer tools like dose calculations, reminders, insulin-on-board tracking, and data sharing with healthcare providers (for example, InPen and Pendiq).

Pen Caps and Smart Add-Ons
These devices attach to standard insulin pens to add tracking and reminder features, such as Bigfoot Unity, GoCap, and Timesulin.

Biosimilar Insulin Pens
Biosimilar pens provide lower-cost alternatives to brand-name insulin, including the Merilog rapid-acting insulin pen.

Recent FDA Activity Highlights

• Medtronic MiniMed Go (January 2026): Cleared as a smart multiple daily injection (MDI) system that integrates InPen technology with glucose sensors to deliver real-time data and dosing recommendations. Approved for people ages 2 and up, with adult supervision.

• GO-PEN (May 2025): Approved as a user-filled insulin pen designed to reduce cost and plastic waste.

• Merilog (February 2025): Became the first rapid-acting insulin biosimilar approved in both vial and prefilled pen formats.

• InPen Expansion: Received expanded FDA approval for use in younger children, starting at age 7.

Key Features and Benefits

• Convenience: Concentrated pens can hold more insulin, reducing how often pens need to be replaced. Disposable pens simplify daily use.

• Smarter Dosing: Companion apps help calculate doses, track insulin on board, and reduce missed or duplicate doses.

• Data Integration: Many pens sync with CGMs and diabetes apps to give a more complete picture of glucose and insulin use.

• Cost and Access: Biosimilars and user-filled pens are designed to lower costs and make insulin more accessible.

Learn more about the MiniMed Go system right here.