Is Thermography FDA Approved? What You Should Know Before Your Scan

Is Thermography FDA Approved?

One of the most common questions people ask before booking a scan is:

👉 “Is thermography FDA approved?”

The answer is nuanced.

Thermography devices are FDA-cleared for use as an adjunctive screening tool.

This means thermography can be used alongside other medical imaging methods, but not as a standalone diagnostic tool.

What Does “FDA-Cleared” Mean?

When a device is FDA-cleared, it means it has been reviewed for safety and intended use.

For thermography, this includes:

• detecting heat patterns

• identifying physiological changes

• assisting in breast health monitoring

  
  

However, it is important to understand how it is intended to be used.

What “Adjunctive Screening” Means

Thermography is considered an adjunctive tool, meaning it provides additional information, not a replacement for other screenings.

It evaluates:

• inflammation

• vascular activity

• heat patterns

  
  

These are functional changes, not structural ones.

👉 Learn more here: Thermography vs Mammogram

Why Thermography Is Still Valuable

Even though thermography is not a standalone diagnostic tool, it offers unique benefits:

Detects Physiological Changes

Thermography identifies how tissue is functioning, not just how it looks.

Radiation-Free

Unlike some imaging methods, thermography uses no radiation.

Useful for Monitoring Over Time

Thermography is especially valuable when used to:

• track inflammation

• monitor changes

• compare scans over time

  
  

👉 See: Why Follow-Up Scans Matter

Common Misconceptions About FDA Approval

Myth: Thermography isn’t approved at all

Truth: It is FDA-cleared for adjunctive use.

Myth: Thermography replaces mammograms

Truth: It is typically used as a complementary tool.

Myth: FDA approval means diagnosis

Truth: Thermography identifies patterns, not diagnoses.

When Thermography Is Most Useful

Thermography is often used by individuals who want to:

• monitor breast health

• detect inflammation

• take a preventative approach

• track changes over time

Frequently Asked Questions

Is thermography approved for breast cancer detection?

Thermography is not used as a standalone diagnostic tool. It helps identify patterns that may require further evaluation.

Is thermography safe?

Yes. It is non-invasive and radiation-free. 

👉 Learn more: Is Thermography Safe?

Thermography is FDA-cleared as a complementary screening tool, meaning it provides valuable physiological information when used alongside other methods.

Understanding how it works—and how it’s intended to be used—can help you make informed decisions about your health.

If you’re considering thermography and want expert guidance, schedule a consultation with ThermaImage today.