Implantable biosensors for chronic disease

Implantable biosensors for chronic disease are surgically or subcutaneously placed sensors that continuously monitor a physiological parameter for months to years, distinct from an external wearable device or a swallowed ingestible sensor. Senseonics’ Eversense 365 recently launched in Europe following European approval as the world’s first and only one-year continuous glucose monitor (CGM), with real-world evidence presented at the ADA and ATTD conferences demonstrating sustained performance and positive patient impact throughout a full year of wear in both open- and closed-loop insulin-delivery systems. Medtronic’s LINQ II insertable cardiac monitor has cleared multiple FDA 510(k) submissions for continuous arrhythmia detection. Boston Scientific’s LUX-Dx insertable cardiac monitor line has also cleared multiple FDA 510(k)s, though the company issued an FDA recall in 2026 for a LUX-Dx II monitoring-system malfunction. Biotronik’s BIOMONITOR IV, its newest insertable cardiac monitor, adds artificial-intelligence-assisted arrhythmia detection, building on the company’s record as the first to implant a leadless pacemaker in the US. In China, MicroPort participates in the country’s growing implantable cardiac and biosensor monitoring device market.

The key directions of implantable biosensors for chronic disease are:

1. Implantable continuous glucose monitoring (Implantable CGM): a subcutaneously placed fluorescence-based glucose sensor providing months-to-year-long continuous readings without sensor replacement — Senseonics’ Eversense 365.
2. Insertable cardiac monitors (Insertable Cardiac Monitors): small subcutaneous devices continuously recording cardiac rhythm to detect intermittent arrhythmia over months to years — Medtronic LINQ II, Boston Scientific LUX-Dx, Biotronik BIOMONITOR.
3. AI-enabled arrhythmia detection (AI Arrhythmia Detection): machine-learning algorithms applied to continuous cardiac rhythm data to improve arrhythmia-detection accuracy and reduce false alerts — Biotronik BIOMONITOR IV.
4. Domestic implantable monitoring devices (Domestic Implantable Monitoring): regionally manufactured and regulated implantable cardiac/biosensor devices serving a domestic market — MicroPort.

Sectoral value chain#

[sensor/device design] ──> [regulatory clearance (FDA 510(k)/MDR/NMPA)] ──> [minimally invasive implantation]
                                                    │
                                       (continuous physiological monitoring)
                                                    │
                                                    ▼
[clinical alert, intervention & device replacement] <─── [data transmission & remote monitoring] <─────┘

Value chain levels#

Cross-cutting technologies of the sector:

• Fluorescence-based implantable glucose sensing (Implantable CGM): a subcutaneous fluorescent polymer sensor continuously measures interstitial glucose, read externally by a transmitter, extending sensor life to a full year in Senseonics’ Eversense 365.
• Subcutaneous cardiac rhythm recording (Insertable Cardiac Monitors): a small, leadless device implanted just under the skin continuously records cardiac electrical activity to catch intermittent arrhythmias that a short-duration Holter monitor would miss.
• AI-assisted signal classification (AI Arrhythmia Detection): machine-learning models applied to continuous cardiac rhythm data distinguish true arrhythmia events from noise/artifact, reducing false alerts sent to the clinical team.

The stack pairs a biocompatible implantable sensor with wireless data transmission and, increasingly, on-device or cloud AI signal processing to extend monitoring duration and improve detection accuracy over external alternatives.

1. Implantable fluorescence-based glucose sensing (Implantable CGM):
   • Senseonics’ Eversense 365 uses a subcutaneous fluorescent polymer sensor read externally by a transmitter, extending continuous glucose monitoring to a full year without sensor replacement — the longest duration in the CGM category.
2. Subcutaneous cardiac rhythm monitoring (Insertable Cardiac Monitors):
   • Medtronic’s LINQ II, Boston Scientific’s LUX-Dx and Biotronik’s BIOMONITOR all implant a small, leadless device just under the skin to continuously record cardiac electrical activity over months to years, catching intermittent arrhythmias a short Holter-monitor window would miss.
3. AI-assisted arrhythmia classification (AI Arrhythmia Detection):
   • Biotronik’s BIOMONITOR IV applies artificial-intelligence-assisted signal classification to continuous cardiac data, aiming to distinguish true arrhythmia events from noise and reduce false clinical alerts.
4. Domestic implantable device manufacturing (Domestic Implantable Monitoring):
   • MicroPort manufactures implantable cardiac and biosensor monitoring devices for China’s domestic market as part of its broader medical-device portfolio.