FDA Class II Telehealth Examination and Diagnosis Device

Executive Summary

Our client is a leading remote home examination and diagnosis solutions company transforming primary care by providing seamless connectivity between patients and clinicians. The client was developing a telehealth solution to replicate a face-to-face clinician visit with a hand-held modular examination tool for examining the heart, lungs, skin, throat, ears, and body temperature.

The telehealth platform includes a cloud-based data repository for sharing and storing exam data, conducting live video exams, and scheduling visits with analytics. The client was looking for help in developing a hand-held examination tool with multiple external adapters to sense and diagnose various body conditions.

Leveraging class II and class III medical device development expertise, and stringent medical software lifecycle process expertise, eInfochips team helped the client with complete product design and development of remote examination device. Qualcomm® partnership and in-house image tuning lab helped the client to shorten the product development life cycle.

Project Highlights

FDA Class II Telehealth Examination and Diagnosis Device
  • Qualcomm® Snapdragon™ 410 based portable home examination modular device
  • Dual camera image tuning for adapters and extensions of telehealth device
  • ISO 13485 and IEC 62304 compliant design
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