4TAVR software from Hi-D Imaging receives approval in the USA

Winterthur – The start-up Hi-D Imaging has received 510(k) clearance from the Food and Drug Administration for its 4TAVR software. The approval confirms the safety and performance of the software, which is intended to improve the preoperative planning of TAVR procedures.

(CONNECT) Technopark Winterthur-based medtech company Hi-D Imaging has received 510(k) clearance from the Food and Drug Administration (FDA) for its 4TAVR software. The software was developed to support transcatheter aortic valve replacement (TAVR) procedures and uses artificial intelligence (AI) and imaging technologies to improve preoperative planning and decision-making. As the company announced on LinkedIn, the approval confirms the safety and performance of 4TAVR and assures its effectiveness for the US market.

510(k) clearance is considered one of the most important procedures for approving medical devices in the USA. With the approval, the 4TAVR software is now available on the American market. The product is now being prepared for MDR (Medical Device Regulation) submission and is currently available in the EU for testing purposes

Hi-D Imaging specializes in cardiovascular diseases and develops, among other things, cloud-based and AI-supported software and computer-aided simulations of medical devices. The company hopes that its technologies will redefine the treatment and understanding of cardiovascular diseases. ce/nta

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