Collaboration between Camgenium and Cardiac Tech for enhancing recovery post-cardiac surgery through implementation of pace-protect system
In an exciting development, the company has partnered with Cardiac Tech to create Pace-Protect, a new medical device designed to improve patient outcomes following open-heart surgery. This innovative device is set to be the first of its kind, utilizing a Soft Silicon mesh network in a clinical environment.
The Pace-Protect device is expected to benefit from several advancements, such as the integration of AI for real-time, adaptive cardiac monitoring and diagnostics. This feature could potentially enable early detection of arrhythmias or complications, enabling timely clinical interventions.
Moreover, the device is designed to adhere to improved regulatory pathways and post-market surveillance, ensuring device safety and effectiveness through continuous data collection and performance review after surgery.
The device's minimally invasive and intelligent features are expected to optimize its function while reducing patient recovery time and complications. Key benefits may include enhanced cardiac rhythm management, better patient monitoring, and increased safety and reliability.
The Pace-Protect prototype has been developed to ISO 13485 and IEC 62304 Class IIa standards, ensuring its quality and safety. It uses a mesh architecture for communications, incorporating Bluetooth Low Energy (BLE), Wi-Fi, cellular, Near Field Communication (NFC), and Long Range (LORA) technologies.
Notably, Camgenium, a leading medical software engineering company, has integrated its proprietary Soft Silicon medical device grade two-way device communications technology into the Pace-Protect prototype. This technology establishes world-class data security for patient confidentiality and high resilience, ensuring individual Pace-Protects never lose contact with the cloud.
The communications electronics for Pace-Protect have been developed by Camgenium. The device is designed to minimize adverse events related to temporary pacemakers and is now planned to go into clinical trials.
Research indicates that there are roughly 1,500 serious adverse events (SAEs) reported each year following open-heart surgery in the US alone, attributable to the management of temporary pacemakers. The Pace-Protect system aims to prevent these SAEs by providing real-time monitoring and alerts.
Camgenium and Cardiac Tech have committed to working together to bring the Pace-Protect prototype to clinical trials. As more specific details on the device become available, a more precise understanding of its benefits and advancements can be outlined.
[1] FDA's focus on streamlined approval and post-market monitoring: https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-program [2] NMPA's emphasis on innovation and regulatory reform: http://en.nmpa.gov.cn/newsClassification/pressRelease/202003/t20200331_227129.html [3] EU's push for AI and data-driven healthcare: https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-for-the-digital-age/artificial-intelligence/ai-healthcare_en [4] Shift towards smarter, personalized care: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066662/ [5] FDA's focus on medical device innovation: https://www.fda.gov/medical-devices/digital-health/medical-device-innovation-consortium-mdic
- The Pace-Protect device, a new medical innovation created through a partnership between the company and Cardiac Tech, is planned to undergo clinical trials, aligning with the FDA's focus on streamlined approval and post-market monitoring.
- As part of the ongoing digital health revolution, the Pace-Protect device, utilizing AI for real-time, adaptive cardiac monitoring and diagnostics, aims to improve health-and-wellness, particularly in managing medical-conditions such as cardiovascular-health, by preventing serious adverse events following open-heart surgery.
- The development and deployment of the Pace-Protect device, incorporating advanced technologies like Bluetooth Low Energy, Wi-Fi, cellular, Near Field Communication, and Long Range, is a significant step towards the EU's push for AI and data-driven healthcare, promoting smarter, personalized care in the realm of science and technology.
