USATherm Receives FDA Clearance for the ThermPix™ Point of Care Infrared Thermography Camera

AVENTURA, FL., May 31, 2022 – USATherm, a healthcare technology company specializing in the development of AI-assisted infrared thermography diagnostic devices to improve the quality and efficiency of medical imaging, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ThermPix Point of Care Infrared Thermography (POCIT) adjunctive diagnostic camera. ThermPix is an infrared thermovisual camera with proprietary software that is designed to view, measure, and record heat patterns and variations in the human body for use as adjunctive diagnostic imaging to other diagnostic medical devices.

USATherm has developed ThermPix initially for the adjunctive diagnosis of venous insufficiency, aiming to serve as a quick and convenient tool for identifying  thermal patterns when used in combination with ultrasound imaging.  ThermPix provides clinicians with the ability to quickly screen for heat variations due to its ease of use and portability. Images captured by the camera are uploaded real time to a HIPAA compliant cloud storage platform. The images can then be accessed from a workstation, laptop, tablet, or phone and shared with patients and clinicians.

ThermPix addresses key challenges faced in diagnostic imaging, namely the lack of a method to easily identify heat patterns and variations. Currently, the standard of care is duplex ultrasound imaging which requires specialized equipment and expertise. ThermPix serves as an easy-to-use, non-contact tool for adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body.

Dr. Ariel Soffer, the founder of USATherm said: “We are pleased to receive the FDA 510(k) clearance for ThermPix and look forward to entering the U.S. market through partnerships with key opinion leaders in the treatment of venous disease, wound care, and other diseases.  ThermPix is a portable, infrared thermovisual, non-contact handheld device used to identify relative heat patterns and irregularities suggestive of abnormal veins.  Our goal is to ultimately evolve and leverage thermography as a standalone diagnostic tool.”

ThermPix thermographic technology is the cornerstone of the company’s product suite, including its AI based predictive diagnostic cloud-based solutions.

About USATherm

USATherm is focused on the development of thermography for use in diagnosing diseases. Their proprietary software features AI learning capabilities that have the potential to transform thermography into a standalone diagnostic tool.  USATherm aims to transform diagnostic imaging with easy-to-use and effective products to enable clinicians to make accurate diagnoses and improve patient lives.  USATherm plans to first launch in the venous insufficiency space, later this year.

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