The First Year

Bubble CPAP System

A bubble CPAP system is a respiratory support device commonly used for newborns with breathing difficulties. It delivers continuous air pressure through the airways, helping keep the lungs open and improving oxygen flow.

Passive Digital Biomarkers: Enabling Continuous and Invisible Health Monitoring

Passive digital biomarkers are transforming modern healthcare by allowing health data to be collected automatically, without requiring patients to actively perform tests or report symptoms. These biomarkers represent a major shift toward continuous, real-world health monitoring powered by digital technologies.

What Are Passive Digital Biomarkers?

Digital biomarkers are objective physiological and behavioral data collected through digital devices such as smartphones, wearable sensors, and connected health technologies.

Passive digital biomarkers specifically refer to health data gathered without conscious effort from the user. For example, a smartwatch measuring heart rate or oxygen levels while a person goes about daily activities generates passive biomarker data automatically.

Medical Device Testing in the U.S.: Ensuring Safety, Quality, and Compliance

Medical device testing in the United States supports the safe development of healthcare technologies used in hospitals, clinics, and home-care settings. Manufacturers rely on specialized testing organizations to evaluate device performance throughout the product development process.

Testing services often include software validation, biocompatibility testing, durability testing, and performance verification. These processes help ensure that devices operate as intended and remain safe for long-term use. Regulatory compliance is a key part of this process, helping manufacturers meet required safety standards.

Healthcare technology is becoming more complex with the growth of digital health devices and connected medical systems. Testing services help verify that both hardware and software components function correctly together.

By supporting innovation while maintaining safety standards, testing organizations play a critical role in advancing healthcare technology in the United States.