In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, announce an acquisition agreement, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).
Appointed longtime Medtronic executive Sean Salmon to its Board of Directors, where he will also serve on the audit and compensation committees. Salmon’s deep operational experience and electrophysiology expertise will support Adagio as the company advances its ultra-low cryoablation technology for ventricular tachycardia.
Appointed former Boston Scientific EMEA President Eric Thepaut as independent Chairman of the Board and released Version 3.5 of its ECGeniusⓇ System. The update adds hardware and software enhancements designed to improve workflow efficiency and system performance as the company prepares for commercial growth in the U.S. and Europe.
Announced that it has received FDA 510(k) clearance for Versius Plus, its second-generation surgical robot, for use in cholecystectomy procedures. With this clearance secured, the company plans to begin commercialization of Versius Plus in 2026.
Reported the world’s first transcatheter treatment of tricuspid regurgitation using its Duo Adapt system. The procedure was performed at Poznan University Hospital in Poland as part of the TANDEM II clinical study of Duo, which works in tandem with the native tricuspid valve to restore valve function.
Received FDA approval for its MarginProbeⓇ 2 system and announced its launch in the U.S. MarginProbe 2 is the company’s next-generation intraoperative margin assessment device for breast-conserving surgery, designed to help surgeons improve precision to improve patient outcomes and reduce the need for additional procedures.
Announced that its Anavi™ System for PCOS-related infertility has received CE Mark certification. The Anavi System is a novel, one-time, office-based procedure designed to restore natural ovulation in women with PCOS-related infertility who don’t respond to, are contraindicated for, or have declined first-line medications.
Received regulatory approval in Spain to initiate its first-in-human MAVERICS Coronary Revascularization Study, evaluating the company’s regenerative small-diameter coronary bypass graft. The milestone advances clinical assessment of the MAVERICS graft, a synthetic vascular scaffold designed to provide a durable alternative to harvested vessels.
Upgraded all deployed Maestro™ systems with active 5G and Wi-Fi connectivity, enabling real-time analytics across its installed base. The update completes Maestro’s edge-to-cloud AI architecture, pairing advanced on-device computing with centralized cloud AI.
Secured full ethical and regulatory approvals to launch the GROSSOⓇ Reshaper REMKERA first-in-human study in Italy, expanding beyond its initial site in Spain. The GROSSO Reshaper is designed to mechanically restore natural corneal curvature to improve vision for keratoconus patients.
Closed an oversubscribed $5M Seed round led by Innosphere Ventures and Stout Street Capital to scale its virtually painless, automation-ready at-home blood collection technology. The funding will support expanded manufacturing, commercial partnerships, and continued development.
Reported promising first-in-human results from the VOID-HF feasibility trial of its JuxtaFlowⓇ Renal Assist Device, including a 70% increase in urine output and an 86% increase in sodium excretion. Building on these results, the company plans to initiate a larger, multicenter study to confirm safety and efficacy and refine treatment protocols.
Appointed Harald Hampel, MD, PhD, MSc, a globally recognized leader in Alzheimer’s disease research and drug development, to its Scientific Advisory Board. Dr. Hampel's expertise will help advance the company’s personalized, non-invasive neuromodulation therapy for Alzheimer’s disease.
Entered a definitive agreement to be acquired by Philips, expanding Philips’ existing intravascular imaging and physiological assessment device portfolio. The acquisition adds SpectraWAVE’s HyperVue™ Imaging System and X1™-FFR angio-based physiology platform into Philips’ leading image-guided therapy ecosystem.
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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