Written by : Saloni Tyagi
May 2, 2025
Camgenium has played a key role in the project, developing both the device’s communication electronics and the digital infrastructure.
Camgenium, a Cambridge-based medical software engineering company, has collaborated with Cardiac Tech, a MedTech innovator, to develop and deploy a groundbreaking medical device, Pace-Protect.
The device aims to enhance patient safety after open-heart surgery by reducing adverse events (AEs) associated with temporary pacemakers.
Pace-Protect functions as a safety system that continuously monitors all aspects of temporary cardiac pacing and instantly alerts clinicians to any acute changes via a cloud-based platform and companion app.
Camgenium has played a key role in the project, developing both the device’s communication electronics and the digital infrastructure.
The company has embedded its proprietary Soft Silicon two-way medical-grade communication technology into the Pace-Protect prototype. Soft Silicon uses a sophisticated mesh communication architecture incorporating BLE, Wi-Fi, cellular, NFC, and LoRa technologies.
The platform is built to ensure high-level data security and resilience, maintaining uninterrupted connectivity with the cloud, even when a patient is being moved within a hospital setting.
The system also supports the transmission of real-time electrogram (EGM) data to clinical teams at high speeds during emergencies.
Notably, Pace-Protect is the first clinical device to utilize a Soft Silicon mesh network.
“We wanted to develop a pioneering solution which enables medical professionals working in high-pressure environments to be alerted of any issues immediately, bringing help to the patient before an adverse event occurs. Partnering with Camgenium is helping to bring our vision to life,” said Will Simpson, CEO at Cardiac Tech.
Traditionally, temporary pacemakers are adjusted manually, but a patient’s pacing needs often evolve as the heart’s conduction system recovers. Undetected changes can lead to the patient’s natural rhythm conflicting with the pacemaker’s impulses.
In the US alone, around 1,500 serious adverse events (SAEs) are reported annually due to temporary pacemaker management. Pace-Protect addresses this by enabling real-time tracking and instant alerts to prevent such outcomes.
“This enabled us to develop a user interface and user workflow that was optimised for clinical use in the hospital and met the regulated and other NHS standards for user interfaces within the highly demanding class II medical device environment,” said Dr Philip Gaffney OBE, CEO at Camgenium.
The device is now being prepared for clinical trials with a fully functioning prototype developed in compliance with ISO and IEC Class IIa standards.