ENDRA Life Sciences, a pioneer in Thermo Acoustic Enhanced UltraSound (TAEUS), recently completed a productive pre-submission meeting with the U.S. Food and Drug Administration (FDA) to discuss the clinical trial design of its TAEUS liver device. The meeting aimed to support the company’s upcoming U.S. De Novo filing. Prior to the meeting, ENDRA provided the FDA with a comprehensive description of the TAEUS technology.
In addition to this update, ENDRA Life Sciences has also revealed its financial results for the fourth quarter and full year of 2023, along with a business update. The company highlighted several significant achievements during the period, including the installation of the first TAEUS system in the UK at Kings College Hospital for clinical evaluation. Kings College Hospital NHS Foundation Trust is a renowned center in London.
Furthermore, ENDRA Life Sciences reported its financial results for the third quarter of 2023, as well as providing a business update. Notably, the company shared positive TAEUS clinical data at the Steatotic Liver Disease Summit 2023, which was hosted by the European Association for the Study of the Liver.
In summary, ENDRA Life Sciences has made remarkable progress in its development and implementation of TAEUS technology. The recent meeting with the FDA signifies a significant step towards the company’s U.S. De Novo filing, which could pave the way for the approval and widespread adoption of its TAEUS liver device. With installations and clinical evaluations taking place at prestigious medical institutions like Kings College Hospital, ENDRA is steadily advancing towards its goal of revolutionizing ultrasound imaging for liver diseases.
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