Ichor is a software package designed to transform off-the-shelf wearable devices into vital sign monitors. Current smartwatches such as the Samsung Galaxy Gear estimate heart rate and blood oxygenation (SPO2) estimation, but lack the ability to provide accurate estimates of patient blood pressure, which is Ichor’s key innovation. Furthermore, no other software platform today allows care providers to monitor patient health in a clinically meaningful manner.
Currently there are two main use cases for Ichor: As a diagnostic tool for assessing hypertension and a cardiovascular care management platform. There is a severe clinical failure to integrate home-based blood pressure monitoring into cardiovascular disease diagnosis and treatment which is why Ichor is extremely valuable as a replacement for ambulatory blood pressure monitors (ABPs). Numerous studies have revealed significant rates of misdiagnosis of hypertension due to static blood pressure measurements in stress-inducing clinical settings. This increases overall quality of care and reduces system-wide costs. Furthermore, doctors lack insight into how various medications affect a patient’s vitals like blood pressure and heart rate throughout the course of a day, week, or month. Having this information can help enable clinicians to perform advanced chronic care management for at-risk patients, saving payors and providers hundreds of millions of dollars. In the long-run our goal is for Ichor to additionally serve as a non-invasive vital sign monitor for use at home as a personal health tool as well as in skilled nursing facilities (SNFs) like rehabilitation centers and assisted living facilities.
- Pandas and Numpy for data wrangling and pre-processing
- Keras, TensorFlow, PyTorch for deep learning
- Tizen Studio (programming in C) for developing Samsung app
- MQTT protocol for sending data from Samsung Galaxy Watch
- AWS for training and prediction
- Samsung Galaxy Watch Active for LED and phototransistors
- MQTT Protocol
- HIPAA Privacy Rule (use de-identified personal health information) -- Development in Eclipse Paho would allow future iterations of the project to support encryption
- Federal Classification 21 870.1130
- Class II Medical Device -- Ichor could go through market through a 510(k) pathway -- Predicate Devices: K190792 BB-613 WP, K181006 BB-613, and K113165 Mini-Medic
Other Standards & Required Testing
- Electromagnetic Compatibility Testing: IEC 60601-1-2:2014
- Cytotoxicity, sensitization and irritation: ISO 10993
- Clinical validation: ISO 80601-2:2013