03/12/2024
SyncVision Website: https://reurl.cc/L5plQ7
Linkedin: https://www.linkedin.com/feed/update/urn:li:activity:7269526557063340033
Development Project for Precision Mobile Healthcare: Digital scope & stethoscope - Image and Heart Lung Sound
・Project Introduction
The COVID-19 pandemic has increased the demand for electronic stethoscopes to reduce the risk of contact-based infections for healthcare professionals. The digital stethoscope market has seen a growing demand. This project focuses on developing a digital quantification and AGC (Automatic Gain Control) algorithm to effectively identify and quantify heart and lung sounds while recording them. It aims to:
1. Provide clinical reference data to doctors promptly.
2. Visualize phonocardiograms, heart murmurs, and heart sound waveforms.
3. Display both auditory and visual diagnostics through a mobile app, enabling doctors to identify heart murmurs more easily.
4. Enhance the accessibility of mobile digital information and offer software-assisted diagnosis.
・Guidance Scope
Based on the IEC 62304 software verification standard, this project validates functions including system boot, firmware calibration and resetting, signal gain verification, and data packet transmission. The AGC algorithm is improved to:
1. Develop and validate designs, manufacturing processes, quality assurance, functional module testing, regulatory safety compliance, and final verification to meet the requirements of medical device quality management systems (QMS/ISO 13485) for certification.
2. Enhance audio signals recorded over a single time axis of the digital stethoscope by zooming in locally and compensating gain while reducing noise interference.
3. Enable remote professional healthcare teams to analyze data without manual adjustments.
・Implementation Outcomes
1. Completed the design, development, manufacturing, quality assurance, packaging, and final verification of a lightweight, portable, and remotely operable digital stethoscope in compliance with ISO 13485 and QMS medical device quality management system standards.
2. Addressed the uneven distribution of healthcare professionals between urban and rural areas by making the digital stethoscope accessible for rural and remote care units, enabling regular checkups and screening of cardiopulmonary functions.
3. Integrated an accompanying app to store cardiopulmonary audio records of elderly patients, issue alerts, and transmit data packets to medical centers for professional review by doctors.
SyncKit is not for FDA cleared devices.
