Washington, D.C. – Global law firm Hogan Lovells Cadwalader advised Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, in connection with the U.S. Food and Drug Administration's (FDA) De Novo classification of its TESSA◊ (Tracking Enabled Spatial Surgery Assistant) Spatial Surgery System, a first-of-its-kind platform designed to bring personalized planning, augmented reality, advanced imaging, navigation, and real-time tracking to arthroscopic procedures.
The FDA's De Novo classification establishes the TESSA◊ System as the first device within a new FDA category for intra-articular orthopedic stereotaxic navigation instruments, creating a regulatory pathway and reference point for future innovations in digital and data-enabled sports medicine technologies. The TESSA System utilizes preoperative MR or CT scans together with cloud-based deep learning algorithms to generate patient-specific three-dimensional anatomical models. The technology overlays these models onto live arthroscopic video to support real-time surgical navigation and visualization. Smith+Nephew's initial indication for the technology is anterior cruciate ligament (ACL) reconstruction procedures, where accurate tunnel placement remains a key clinical consideration.
The matter reflects Hogan Lovells Cadwalader's deep experience advising life sciences and medical technology companies on novel regulatory pathways, including FDA clearance, authorization, and approval matters involving cutting-edge medical devices, software-enabled technologies, artificial intelligence, and digital health solutions. The Hogan Lovells Cadwalader team advising Smith+Nephew was led by partners Randy Prebula and Kristin Zielinski Dugan, senior associate Megana Sankaran, senior director of regulatory strategy Michael Kasser, director of regulatory sciences Alex Smith, director of regulatory affairs Ryan Foringer, and senior regulatory specialist Mike Mortillo.