Is the CONNEQT Pulse FDA-Cleared?

Yes, the CONNEQT Pulse is FDA-cleared, ensuring that it meets the stringent safety, accuracy, and performance standards required for medical devices in the United States. This designation means the device has been thoroughly evaluated and tested for its intended use in measuring arterial health metrics.

What Does FDA Clearance Mean?

FDA clearance is granted to medical devices that demonstrate substantial equivalence to an already legally marketed device in terms of safety and effectiveness. For the CONNEQT Pulse, this means:

• Proven Accuracy: The device provides reliable measurements of central blood pressure, arterial stiffness, and other biomarkers.

• Safety Standards: It has been tested to ensure it is safe for regular use by individuals with a range of health conditions.

• Clinical Relevance: The Pulse delivers data that healthcare providers can use to make informed decisions about your arterial health and treatment.

Why FDA Clearance Matters

Choosing an FDA-cleared device like the CONNEQT Pulse offers you:

• Confidence in Results: The rigorous evaluation process ensures that the data you receive is accurate and clinically validated.

• Peace of Mind: You can trust the device to meet high-quality standards for safety and performance.

• Support for Health Goals: With its advanced arterial health insights, the Pulse empowers you to monitor and manage your cardiovascular health effectively.

What Makes the Pulse Unique?

Unlike traditional blood pressure monitors, the CONNEQT Pulse goes beyond basic measurements to provide a comprehensive view of your arterial health. Its FDA clearance reflects its ability to deliver advanced metrics like:

• Central Blood Pressure

• Augmentation Index (AIx)

• Arterial Stiffness

• Subendocardial Viability Ratio (SEVR)

These insights help you and your healthcare provider better understand your cardiovascular health and track progress over time.

By choosing the CONNEQT Pulse, you’re opting for a trusted, FDA-cleared device that delivers advanced arterial health monitoring with precision and safety. For more information about the device or its FDA clearance, visit the Support Center or reach out to CONNEQT Support.