In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni achieve regulatory milestones, appoint new executives, welcome new board members, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).
Received FDA Breakthrough Device Designation for its vCLAS™ Cryoablation System, a novel therapy for recurrent, drug-refractory, sustained monomorphic ventricular tachycardia. The designation validates Adagio’s proprietary ULTC technology and supports priority FDA review as the company advances its pivotal FULCRUM-VT study toward pre-market approval.
Was awarded the CE Certificate for compliance with EU Medical Device Regulation 2017/745 for its Ultravision2 surgical smoke management system. The approval supports the broader adoption of Ultravision2’s advanced smoke control and visualization benefits in both open and minimally invasive surgery.
Appointed Ray Baker, M.D., to its Board of Directors, bringing over 35 years of clinical and executive experience in interventional pain management. Dr. Baker’s addition supports Arsenal’s continued advancement of its NeoCast™ and ResQFoam™ products and the development of novel biomaterials for new therapeutic applications.
Secured full ownership of its foundational patent portfolio for the Atmo Gas Capsule through an IP assignment agreement with RMIT University. The agreement, which includes an equity stake for RMIT, strengthens Atmo’s IP position ahead of FDA regulatory milestones and supports long-term commercialization plans.
Partnered with Hemeo, a digital health company focused on blood coagulation management, to serve as Fractional CFO and capital raise advisor, supporting strategic financial planning and fundraising. The collaboration reinforces Berg Capital’s role as a value-added partner for early-stage healthcare companies scaling through critical growth milestones.
Rebranded from Satisfai Health to Dova Health Intelligence, signaling a broader commitment to advancing intelligence-driven GI care. Alongside a refreshed identity, the company’s products have also evolved—Certai becomes DovaVision, and Sonai becomes DovaSound—underscoring its mission to deliver real-world clinical impact.
Received FDA approval for the WiSE® System, the world’s first and only leadless left ventricular endocardial pacing (LVEP) device for cardiac resynchronization therapy (CRT). Designed to overcome the limitations of conventional CRT, WiSE expands treatment access for heart failure patients previously considered untreatable due to anatomy, lead failure, or procedural risk.
Enrolled and treated the first pediatric patient in its clinical study for short bowel syndrome (SBS) at Cincinnati Children’s Hospital. The milestone marks a significant step forward for Eclipse Regenesis and its regenerative therapy, which is designed to restore intestinal length and function in children with SBS.
Announced $14.3M in financing to support commercialization of its EggNest shielding system for X-ray-guided procedures. Designed to reduce scatter radiation exposure by over 90%, Egg Medical’s technology offers a safer, more practical alternative to traditional lead aprons.
Appointed Michael Nagel as its new Chairman of the Board to support strategic growth and commercialization efforts. With extensive medtech leadership experience, Nagel joins EndoShunt Medical as it advances its novel hemorrhage control system designed to revolutionize trauma care.
Received FDA IDE approval to initiate U.S. clinical trial for the CartRevive® hydrogel implant for cartilage repair. This milestone enables Hy2Care® to evaluate its minimally invasive solution for traumatic cartilage injuries in the knee in the United States, building on positive clinical results in Europe and advancing toward global regulatory and commercial milestones.
Completed its 175th surgical procedure using the OsteoPearl™ biological allograft implant for vertebral compression fractures. The milestone highlights Lenoss Medical’s growing commercial momentum and the clinical adoption of its innovative, natural bone healing solution.
Co-founders Lucrezia Cester and Dilip Rajeswari were featured in Forbes 30 Under 30, marking a milestone in the company’s mission to close the cardiovascular gender diagnosis gap with its AI-powered LightScope device. The 10-second, non-contact scan detects heart conditions through clothing without expert intervention, aiming to deliver earlier, more equitable diagnoses for patients worldwide.
Appointed LSI Alumni Steffen Hovard as Executive Board Chair to help accelerate the company’s mission of advancing digital home health solutions. With a strong track record in medtech leadership, Hovard brings strategic guidance to support Minze Health’s global growth and impact on patients.
Received FDA 510(k) clearance for NEAT (Neurosom™ EEG Assessment Technology) medical device software. NEAT, developed with BEL’s AI platform using convolutional neural nets, classifies sleep stages in two modes (online/near-real-time or offline) from EEG data.
CEO & Founder Maxwell Munford was featured in the Forbes 30 Under 30 list. The recognition highlights his leadership and the company’s dedication to developing next-generation knee implants that combine innovative 3D-printed articulating surfaces with biomimetic cementless fixation for enhanced functionality, superior fixation, and a long-lasting bone foundation.
Appointed Marc Korenberg as Chief Financial Officer, bringing over 15 years of leadership in finance, biopharma, and medtech. His strategic expertise and people-first approach will support Phagenesis as it advances its mission to transform care for patients with neurogenic dysphagia.
Announced the final close of its inaugural fund with $50M in assets under management, marking a major milestone for SPRIG Equity’s mission to improve patient outcomes through transformative medtech investments. The firm has already backed four companies across neuromodulation, structural heart, and diagnostics.
Announced the first procedure using Maxx Orthopedics’ Freedom® Total Knee implant with THINK Surgical’s TMINI® Miniature Robotic System. The milestone highlights the growing adoption of open-platform, handheld robotic systems that support surgeon-preferred implants and aim to improve outcomes in total knee arthroplasty.
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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