1. Rapid Integration of Sensor Technology in Clinical Trials: The adoption of smartphones and biosensors has grown significantly in the past decade, with an expected 70% of clinical trials incorporating sensors by 2025.
2. Critical Differences Between Medical-Grade and Consumer-Grade Devices: Understanding the distinctions between medical-grade and consumer-grade devices is crucial. Medical-grade devices adhere to regulatory definitions and classifications, ensuring compliance with global clinical trial regulations, while consumer-grade devices are geared for everyday use with varying levels of FDA clearance.
3. Guidance for Successful Sensor Solution in Clinical Trials: Medical-grade sensors, backed by FDA clearance and adherence to regulatory requirements, inspire higher confidence in successful implementation and regulatory submission.