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BIOSENSORS · CGM · CLINICAL & COMMERCIAL APPS



Biosensor & CGM App Development — From Clinical Studies to Commercial Launch

Biosensor and CGM software is the app and cloud layer that turns sensor data into something patients, researchers, and clinicians can use, from the first clinical study through commercial release. 
Sequenex builds the mobile and cloud applications for biosensor, CGM, and connected diabetes products, with shipped clinical app experience and a software foundation that grows from MVP to commercial scale.
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Mobile & Cloud App Development for Biosensor, CGM, and Diabetes Products

Biosensor and CGM products need software that evolves with them: a clinical study app to gather early evidence, then a commercial app built for scale. Sequenex builds the mobile and cloud layer across that journey, from MVP through clinical studies to commercial launch.

  • 01

    Clinical Study App Development

    Mobile and cloud apps for biosensor and CGM clinical studies: data collection, participant management, and the evidence infrastructure your study depends on.
    • iOS and Android apps for first-in-human, feasibility, and clinical investigation studies
    • Real-time and historical sensor data visualization for study participants and teams
    • Data collection, cloud synchronization, and audit logging built for study integrity
    • Built on a foundation that carries forward into your commercial product, not thrown away after the study

  • 02

    CGM & Biosensor Companion Apps

    iOS and Android companion apps for continuous glucose monitoring and biosensor products: real-time data display, trends, and alerts.
    • Native iOS and Android apps that present the glucose and sensor data patterns users expect
    • Real-time graphs and charts, trend arrows, time-in-range views, and configurable alert thresholds
    • Carb logging, event correlation, and reporting that connect sensor data to context
    • Designed for engagement and built to your human factors and usability requirements

  • 03

    Commercial App Development & Scale

    Taking your biosensor or CGM app from clinical validation to commercial launch: scalability, quality system integration, and the engineering rigor commercial release requires.
    • Commercial-grade iOS and Android apps built to scale with your user base
    • Engineering aligned to the documentation and validation your commercial release requires
    • Quality system integration so the move from clinical to commercial is not a rebuild
    • Cybersecurity and data protection from Day One and matured for commercial deployments

  • 04

    Cloud & Data Foundations

    HIPAA-ready cloud infrastructure for biosensor and CGM data: collection, storage, and analytics foundations that scale from study to commercial.
    • HIPAA-ready cloud architecture for sensor data collection, sync, and backup
    • Analytics and reporting foundations your application can extend, scoped to your needs
    • Time-in-range, glycemic variability, and other CGM metrics where your product requires them
    • Data structured today to support the regulatory, clinical, and reimbursement evidence you will need tomorrow
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WHY SEQUENEX



Why Biosensor and Diabetes Companies Build Their Apps With Sequenex

We have built and delivered clinical apps: the software companies rely on to gather early evidence and move toward submission. In the biosensor, CGM, and diabetes space, that means apps that collect sensor data, support studies, and hold up to the documentation and data standards a regulated program requires. You get a team that has done this work, not one learning it on your timeline.CGMs, insulin pumps, smart pens, glucose meters, and connected biosensor wearables all introduce unique software and connectivity challenges. Projects benefit from reusable architecture patterns informed by real-world connected diabetes workflows — from BLE pairing edge cases and long-duration data handling to sensor drift, OTA updates, and traceable data collection.

A biosensor or CGM program does not need one app for the clinical study and a different one rebuilt for launch. Sequenex builds on a configurable foundation that carries from MVP through clinical studies to commercial release, so the engineering compounds across stages instead of restarting at each one.

FDA pathways for CGM, biosensor, and connected diabetes software carry specific expectations. Our engineering work aligns to the regulatory framework your team defines, producing the software documentation, V&V evidence, and traceability that feed your team’s submission.

A CGM or biosensor program does not have to wait for finished sensor hardware to start building software. Using device simulators that reproduce realistic data streams, sensor behavior, and signal patterns, including CGM simulators that model true-to-life glucose data, Sequenex builds and tests the companion app, alerts, and cloud pipeline against realistic data before the physical sensor exists. The software, validation evidence, and documentation advance in parallel with your hardware development rather than behind it.

FDA pathways for CGM, biosensor, and connected diabetes software carry specific expectations. Our engineering work aligns to the regulatory framework your team defines, producing the software documentation, V&V evidence, and traceability that feed your team’s submission.

 Discuss Your Biosensor or CGM Project
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Built for Scale, Designed for Compliance

Every biosensor and CGM app we build is engineered under the rigor of our ISO 13485-certified QMS, with engineering deliverables (V&V evidence, cybersecurity artifacts, technical documentation) produced through our continuous delivery / continuous compliance process and structured to integrate directly with your regulatory team’s work.

App Development

iOS, Android, cloud
Advanced analytics
Lifecycle CoverageMVP, clinical study, commercialization
Custom branding
VerticalsCGM, biosensors, connected diabetes, remote patient monitoring
Storage integrations
AI assistant
Automated reports
Standards AlignmentIEC 62304, ISO 13485, ISO 14971

Ready to Build Biosensor or CGM Software?

Whether you're launching a new biosensor, upgrading a CGM platform, or integrating connected diabetes devices, the conversation worth having is what your software stack actually needs. Let's have it.
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