The start-up Hi-D Imaging has received 510(k) clearance from the Food and Drug Administration for its 4TAVR software. This approval confirms the safety and performance of the software, which is designed to improve the preoperative planning of TAVR procedures.
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 efficacy for the US market.
510(k) clearance is considered one of the most important procedures for authorising medical devices in the USA. With the approval, the 4TAVR software is now available on the US 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 cloud-based and AI-supported software and computer-aided simulations of medical devices, among other things. The company hopes that its technologies will redefine the treatment and understanding of cardiovascular diseases. ce/nta
