In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funds, receive regulatory approvals, and much more on the road to LSI Europe ‘25 in London (September 7-11).
Completed the final design review of its proprietary nerve-sensing catheter, a key milestone toward initiating U.S. clinical studies. The microchip-based catheter enables real-time detection and differentiation of nerve signals from within the vasculature, supporting a “sense, treat, and verify” approach for applications including pancreatic cancer pain.
Received FDA 510(k) clearance for its NeedleVue™ LC1 Ultrasound System, a foundational milestone for DeepSight’s next-generation imaging platform. The system enhances image-guided procedures with sub-millimeter precision, aiming to improve visualization, procedural efficiency, and user confidence.
Received Class III Medical Device Registration approval in China for the Intelligent SpinePecker, a miniature orthopedic surgical robot developed through its joint venture with HICREN. The system, based on Interventional Systems’ Micromate technology, offers ultra-high precision in a compact, mobile form factor designed to streamline minimally invasive spine procedures.
Raised a $20M Series A funding round led by Cleveland Clinic, JobsOhio Growth Capital Fund, and a Private Family Office. The company has developed a novel ultrasound platform for robotic surgical guidance.
Received FDA approval for the GenioⓇ system, a leadless, wearable-powered bilateral neurostimulation device for a subset of patients with moderate to severe obstructive sleep apnea. The approval clears the way for U.S. commercialization following positive DREAM trial results, which demonstrated significant efficacy regardless of patient sleep position.
Raised $61M in Series B funding and enrolled the first patient in its FASTR II pivotal trial for acute decompensated heart failure. The proceeds will support clinical trial execution and commercial readiness for the Reprieve system, an intelligent decongestion management therapy designed to optimize fluid removal and reduce readmissions.
Received CE Mark certification for its SurgiField System devices, enabling commercial distribution across Europe and global expansion. The ultraportable platform creates a sterile surgical environment at the point of need, aiming to improve access to safe, clean surgery in both resource-limited and high-resource settings.
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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