Another FDA approval for Naviswiss

Another FDA approval for Naviswiss unknown

Two of NaviSwiss' products are currently being used in the United States. The Swiss medtech startup has obtained another green light from the United States Food and Drug Administration to market its new product Naviswiss Knee in the United States. The product will be rolled out later this year.

NaviSwiss develops miniaturized orthopaedic surgical, tracking and navigation systems that yield immediate results, simplify workflows and minimize the time and cost of surgical procedures. Its product portfolio comprises Naviswiss Hip, a navigation technology for hip replacement surgery and Naviplan, a digital pre-operative planning solution that enables orthopaedic surgeons to perform navigated CT-based total hip replacement surgery – both products are currently used in the US market Japan, Australia and selected EU Markets. Naviswiss Hip CT, which is optimized for complex cases, reads digital planning and assists with digital cup alignment, leg length and offset. The first cases have been conducted in the US.

The receipt of the United States Food and Drug Administration (FDA) approval to commercialise the Naviswiss Knee solution marks another key milestone in the startup’s journey. Naviswiss Knee is a landmark-based navigation application that assists the surgeon in the optimal positioning and alignment of knee replacement implants. The product allows orthopaedic surgeons to choose between an express workflow with navigated Flexion/Extension and Varus/Valgus alignment only or the Advanced Workflow with additional navigation of Medial and Lateral resection height and Range of Motion overviews.

“Naviswiss Knee is an important addition to our Naviswiss System Platform further expanding our offering for navigated joint replacement”, said Jan Stifter, Naviswiss CEO. “We now have a patient-specific option also for total knee replacement where the surgeon determines the best application for the procedure. With Naviswiss Knee we stay tight to our core innovation principles, delivering smart, small and accurate technology to the benefit of all involved in the care chain, not least the patient himself. The addition of our Knee Navigation solution represents a massive opportunity to accelerate Naviswiss’ growth journey.”

The next steps include a limited market release in the United States with established surgical partners. The full launch of Naviswiss Knee Navigation is planned to be rolled out to orthopaedic centers across the United States during the latter half of 2023.

(Press release/RAN)