In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funding, receive regulatory approvals, achieve clinical milestones, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).
Welcomed LSI Alumni Joe Mullings to its Advisory Board, bringing one of the most connected and trusted leaders in global medtech to support the company’s growth. Mullings’ strategic guidance and industry-wide reach will help AccuLine scale its CORA platform in the U.S. and advance toward its Series A.
Announced a $53M first close in its Series C financing to advance development of the Katana™ Thrombectomy System and NavIQ™ quantification software. The funding will also support completion of QUADRA-PE enrollment, regulatory submissions, and the establishment of a joint venture in Qatar.
Secured FDA 510(k) clearance for its fully integrated HOTWIRE™ Transseptal Access System, which includes the HOTWIRE RF Guidewire and the HOTWIRE RF Generator. The company also shared that the HOTWIRE RF Guidewire, which received 510(k) clearance in May of 2024, has now been successfully used in nearly 2,000 clinical procedures.
Treated the first patient in the SAPPHIRE Trial evaluating the VisiPlateⓇ glaucoma treatment device in patients with open-angle glaucoma. The procedure marks the start of the prospective, multicenter, open-label trial, which will assess safety and effectiveness to support future FDA applications.
Announced the launch of the FIZE kUOⓇ system in Japan through an exclusive partnership with Asahi Kasei Medical. The collaboration expands access to real-time kidney insights for ICU teams, supporting earlier detection of deterioration and more precise, data-driven fluid management at the bedside.
Announced an acquisition deal with Emmetros Limited to enhance Stream Inara™, its AI-powered patient education and engagement platform. Emmetros is the developer of SparxConnect™, a secure, customizable engagement and collaboration platform for home, residential, and surgical care.
Received FDA 510(k) clearance for the VanquishⓇ Water Vapor Ablation System for prostate tissue ablation in intermediate-risk prostate cancer. The clearance, supported by positive VAPOR 2 study data, enables commercial launch and advances the company toward expanded indications.
Completed the first two patient treatments in the ASCEND first-in-human study evaluating the Cygnum™ Aneurysm Sac Management Device. The early procedures demonstrated successful integration into the EVAR workflow, supporting continued enrollment and the company’s global clinical development efforts.
Achieved its first CE mark certification, enabling the introduction of its mixed reality solutions across Europe. The certification positions MediView to bring advanced extended reality tools to hospitals and healthcare systems and support more efficient, collaborative, and image-guided interventions.
Announced that the AMA issued a new CPT code for lymphovenous bypass (LVB) surgery and that the CMS finalized and released a payment rate for LVB procedures performed in an outpatient setting. Together, these actions create initial reimbursement for a procedure that previously required billing under unlisted surgical codes.
Received FDA 510(k) clearance for the NelliⓇ Seizure Monitoring System in the hospital setting, expanding epilepsy diagnostics and monitoring capabilities in U.S hospitals. Commercial rollout is planned for early 2026, with priority focus on major academic hospitals and high-volume epilepsy centers.
Announced a strategic partnership with LSI Alumni company Interventional Systems to develop a shoulder-specific micro-robotic solution that will integrate with the company’s ProVoyanceⓇ ecosystem. The collaboration aims to enhance surgical precision and workflow efficiency, offering a portable robotic solution tailored for ambulatory surgery centers.
Promoted LSI Alumni speaker Spencer Stiles to President and COO, expanding his leadership to oversee global business, strategy, and M&A beginning January 2026. Stiles brings 27 years of experience across Stryker’s Orthopedics, MedSurg, and Neurotechnology businesses, reflecting a long track record of performance and leadership.
Established an expanded presence in Israel to strengthen support for the country’s medtech ecosystem and connect Israeli innovation to global markets. The initiative, led by industry veteran Ido Hadari, deepens TMG’s in-country relationships and enhances its ability to help Israeli-founded companies scale in the U.S. and worldwide.
Secured nearly €50M in new financing from the European Investment Bank and existing investors to advance commercialization of aXess, its vascular access conduit for hemodialysis. This follows the recent announcement of exceptional clinical data from its EU pivotal trial of aXess, which demonstrated major improvements across all key clinical metrics compared with the current standard of care.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.
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