FORT LAUDERDALE FL., September 14, 2023 – USATherm, a leading innovator in the field of medical thermal imaging technology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a 510(k) on it’s 2nd generation thermal imaging device.
ThermPix™ leverages cutting-edge thermal imaging technology to provide high-resolution, real-time thermal images of the human body. This non-invasive and non-ionizing imaging device has the potential to transform the way healthcare professionals screen, diagnose and manage a wide range of conditions. The technology allows healthcare providers detect temperature variations, aiding in the screening and early diagnosis of a number of conditions when used adjunctively with other diagnostic modalities
The FDA approval process involved rigorous testing and evaluation, demonstrating the safety and accuracy of ThermPix™. Our team at USATherm is committed to upholding the highest standards in product development and regulatory compliance, ensuring that healthcare providers and industries can trust the accuracy and reliability of our technology.
“We are thrilled to receive FDA approval for ThermPix™ which represents a significant step forward in the field of thermal imaging technology,” said Eric Heil, Chief Executive Officer of USATherm, Inc. “We believe that this technology has the potential to revolutionize healthcare by enabling early disease detection and improving patient outcomes. This achievement reflects our dedication to innovation and improving the quality of life for patients worldwide.”
USATherm is now preparing for the production and distribution of ThermPix™ to healthcare facilities and providers across the United States with the initial focus on peripheral vascular disorders. The company is planning for its commercial launch into the U.S. at the upcoming 2023 UIP World Congress & AVLS 37th Annual Congress September 17 – 21, 2023.
USATherm is focused on the development of thermography for use in screening and diagnosing diseases. The 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.
For more information, please visit www.usatherm.com or call 1. 844.998.4376