IRELAND – Medtronic has received U.S. Food and Drug Administration (FDA) clearance for its new InPen app, a critical component of the company’s Smart Multiple Daily Injection (MDI) system.
This milestone positions Medtronic as a leader in diabetes care, introducing a system that combines advanced insulin delivery and continuous glucose monitoring to provide real-time, personalized dosing insights.
The Smart MDI system integrates Medtronic’s InPen smart insulin pen with the Simplera continuous glucose monitor (CGM), a disposable, all-in-one device designed to streamline diabetes management.
It is set to be the first system to offer recommendations for correcting missed or inaccurate insulin doses—a common issue among diabetic patients.
Missed doses are a significant challenge, with studies estimating that one in three insulin doses is skipped, increasing the risk of both short- and long-term complications.
The Missed Dose alert feature aims to address this issue, enhancing patient adherence and reducing glucose spikes.
The InPen communicates with a mobile app via Bluetooth, offering features such as dose calculation, tracking, and missed meal dose identification.
This app calculates optimal insulin doses based on real-time glucose levels, carbohydrate intake, and existing insulin activity.
With precise dosing capabilities in half-unit increments, it provides a seamless, pump-free solution for diabetes management.
The Simplera CGM, cleared in September 2023 with a CE mark, is designed for individuals aged two and older.
It offers a no-fingerstick solution and is compatible with iOS and Android devices. Its integration into the Smart MDI system further strengthens Medtronic’s commitment to simplifying diabetes care.
Medtronic plans to initially roll out the system to existing CGM and InPen users, with a broader commercial launch to follow.
Significance of FDA clearance
The FDA’s approval is a pivotal moment for Medtronic’s diabetes business, adding to its growing portfolio of innovative solutions.
The company has experienced strong adoption of its MiniMed 780G automated insulin delivery system, increased CGM attachment rates, and the successful rollout of Simplera Sync.
This momentum is reflected in market optimism, with Medtronic’s stock price rising 0.7% to US US $84.74 following the announcement.
Medtronic has a market capitalization of US $116.2 billion and has consistently delivered earnings surprises, averaging 3.07% over the past four quarters.
A growing market for Medtronic
The global diabetes devices market was valued at US $30.31 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 7.45% through 2030, according to Grand View Research.
This growth is driven by rising diabetes prevalence, advancements in technology, and increased use of insulin delivery devices.
The FDA clearance of the Smart MDI system builds on Medtronic’s recent successes, including approval for its Affera Mapping and Ablation System.
Additionally, the company presented long-term data from its SPYRAL HTN-ON MED clinical trial at the 2024 Transcatheter Cardiovascular Therapeutics Conference.
