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Therma Bright Submits Updated FDA 510K Application Requesting Correction of Venowave Device's Intended Use, Labeling, and Description
Toronto, Ontario--(Newsfile Corp. - September 7, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: ...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Submits Updated FDA 510K Application Requesting Correction of Venowave Device's Intended Use, Labeling, and DescriptionToronto, Ontario--(Newsfile Corp. - September 7, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (\"Therma\" or the \"Company\"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, announced today the Company has submitted an updated U.S. Food and Drug Administration (FDA) 510K application to correct the Venowave device's intended use, labeling and product description in order to better address the U.S. Centers for Medicare and Medicaid Services (CMS) application for permanent Current Procedural Terminology (CPT®) / Healthcare Common Procedure Coding System (HCPCS) codes.In late August, CMS asked the Company to first secure approval from the FDA through an updated 510K application stating that the Venowave device can be used successively by multiple patients. This was a key requirement for the Company to secure in order to update its CMS application to secure the nine (9) permanent CPT® and HCPCS codes.\"Our team worked quickly to prepare this first step in updating our FDA 501K application for our Venowave device, specifically around the use, labeling and device description,\" shared Rob Fia, CEO of Therma Bright. \"Once we secure FDA approval on our updated 510K application, our team will be ready to address the second step of updating our CMS application stating that the Venowave can be used successively by multiple patients. We are cautiously optimistic that this change, along with some other minor changes, to our updated FDA application, and subsequent CMS application, will result in a positive decision on our CPT® and HCPCS codes.\"The Company looks forward to providing more information as it becomes available on the unique permanent CPT® and HCPCS codes and on expanding its distribution partners across the U.S. for its Venowave device.About Therma Bright Inc.Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: ...