FDA Approves Truvian Health’s Blood Testing Platform

TruVerus™ device for blood testing in a medical facility

San Diego, December 17, 2025

Truvian Health’s TruVerus™ system has received FDA clearance, revolutionizing point-of-care diagnostics by enabling lab-quality blood tests to be conducted in minutes at the patient’s location. This innovation enhances immediate medical decision-making while reducing the need for centralized laboratory services. The platform integrates various testing methods, requires minimal samples, and is designed for user-friendly operation across healthcare settings, promising to improve overall patient outcomes, particularly in urgent care situations and underserved areas.

San Diego, CA – FDA Clears Truvian Health’s Blood Testing Platform

Truvian Health’s TruVerus™ system has received FDA clearance, marking a significant advancement in point-of-care diagnostics. This approval allows healthcare providers to perform lab-quality blood tests in minutes, directly at the patient’s location, enhancing immediate medical decision-making.

Key Features of TruVerus™

  • Comprehensive Testing: Integrates clinical chemistry, immunoassay, and hematology in a single, compact device.
  • Rapid Results: Delivers accurate results within minutes, facilitating timely medical interventions.
  • Minimal Sample Requirement: Requires only a small blood sample, reducing patient discomfort and simplifying the testing process.
  • Automated Operation: Fully automated and user-friendly, designed for seamless integration into various healthcare settings.

Implications for Healthcare Delivery

The FDA clearance of TruVerus™ represents a pivotal moment in healthcare diagnostics. By enabling on-site, rapid blood testing, it aims to reduce the dependency on centralized laboratories, decrease turnaround times, and improve patient outcomes through quicker diagnoses and treatments. This innovation is particularly beneficial in urgent care scenarios and underserved areas where access to traditional lab facilities may be limited.

Background on Truvian Health

Founded in San Diego, Truvian Health has been at the forefront of developing accessible and efficient diagnostic solutions. The company’s mission is to make routine health testing convenient, affordable, and actionable for consumers. With the clearance of TruVerus™, Truvian continues to advance its vision of transforming healthcare delivery by bringing lab-quality diagnostics closer to patients.

Looking Ahead

Truvian Health plans to expand its test menu by pursuing additional FDA clearances for various health panels. This strategic approach aims to offer a comprehensive suite of diagnostic tests, further solidifying TruVerus™ as a versatile tool in modern healthcare.

Frequently Asked Questions (FAQ)

What is TruVerus™?

TruVerus™ is Truvian Health’s FDA-cleared blood testing platform that integrates clinical chemistry, immunoassay, and hematology in a single, compact device, providing lab-quality results in minutes.

How does TruVerus™ benefit healthcare providers?

Healthcare providers can perform on-site, rapid blood tests, reducing reliance on centralized laboratories, decreasing turnaround times, and enabling quicker medical decisions, especially in urgent care scenarios.

What are the key features of TruVerus™?

  • Comprehensive Testing: Integrates multiple diagnostic tests in one device.
  • Rapid Results: Provides accurate results within minutes.
  • Minimal Sample Requirement: Uses a small blood sample.
  • Automated Operation: Fully automated and user-friendly.

What is Truvian Health’s mission?

Truvian Health aims to make routine health testing convenient, affordable, and actionable for consumers, transforming healthcare delivery by bringing lab-quality diagnostics closer to patients.

What are Truvian Health’s future plans?

Truvian Health plans to expand its test menu by pursuing additional FDA clearances for various health panels, aiming to offer a comprehensive suite of diagnostic tests and further solidify TruVerus™ as a versatile tool in modern healthcare.

Key Features of TruVerus™

Feature Description
Comprehensive Testing Integrates clinical chemistry, immunoassay, and hematology in a single device.
Rapid Results Delivers accurate results within minutes, facilitating timely medical interventions.
Minimal Sample Requirement Requires only a small blood sample, reducing patient discomfort and simplifying the testing process.
Automated Operation Fully automated and user-friendly, designed for seamless integration into various healthcare settings.


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STAFF HERE SAN DIEGO WRITER
Author: STAFF HERE SAN DIEGO WRITER

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