The Weekly Recap 4/10/26: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni appoint new executives, receive regulatory approvals, secure funding, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

Adagio Medical

Received FDA IDE approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT). The approval enables the company to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System, including the next-generation vCLAS Ultra catheter, which has been built on the clinical foundation established by the company’s all-endocardial ULTA technology.

Anumana

Received FDA clearance for its ECG-AI™ algorithm for cardiac amyloidosis (CA), the first and only cleared for this indication using standard 12-lead ECGs. The AI-enabled SaMD, previously granted FDA Breakthrough Device Designation and selected among the first 15 devices in the FDA’s Total Product Life Cycle Advisory Program pilot, is designed to help clinicians identify patients who may be at risk for CA at the point of care.

Axoft

Commenced a new clinical research study with Mass General Brigham, bringing the total number of implantations using its Fleuron™ probes to 11 patients across three different clinical sites. This latest study focuses on cortical mapping, seizure onset mapping around tumors, and language recognition.

Broadview Ventures

Welcomed LSI Alumni Kelly Krajnik as its Director, Head of MedTech. Krajnik, who brings 20 years of experience in early-stage technology scouting, new company formation, business development, and corporate venture capital, will be responsible for managing the day-to-day strategy and investment activities of the company’s medtech practice, including identification and screening of new opportunities, due diligence, negotiation of deal structure, and portfolio company board involvement.

CorTec

Received FDA Breakthrough Device Designation for its Brain Interchange™ System, which combines neural signal recording with adaptive stimulation in a closed-loop system. The designation covers the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments.

Endospan

Received FDA approval for its NEXUS^Ⓡ Aortic Arch Stent Graft, a device designed to treat complex aortic arch disease in patients who are at high risk for open surgery. The approval was supported by one-year results from the TRIOMPHE Investigational Device Exemption study that demonstrated that the device could safely and effectively treat conditions, including chronic aortic dissections in high-risk surgical patients.

Endovascular Engineering

Closed an oversubscribed $80M Series C financing co-led by Gilde Healthcare and Norwest, with participation from Santé Ventures, 415 Capital, S3 Ventures, Panakès Partners, M&L Healthcare Investments, existing undisclosed strategic investors, and a new global strategic investor. The financing supports the commercialization of E2’s novel HēloⓇ Thrombectomy Platform for pulmonary embolism, which addresses limitations of legacy systems with a patented dual-action mechanism that combines aspiration and mechanical clot disruption to deliver large-bore performance through a small-profile catheter for efficient single-pass procedures.

FeelTect

Announced the start of its clinical trial in Ireland at the University of Galway to evaluate the Tight Alright, the company’s system for remotely monitoring sub-bandage pressure applied during compression therapy for venous leg ulcers (VLUs). The device measures pressure at three points on the lower leg and sends information wirelessly to a mobile app that shows real-time pressure readings and sends data to a secure cloud database for a healthcare team to monitor.

FIZE Medical

Completed a $6M warrant exercise, bringing its total Series A financing round to $36M. The company will use the additional capital to expand across the U.S., Europe, and Japan, further R&D for next-generation AI-driven fluid management, and expand clinical validation studies within leading hospitals, all to advance the company's vision of transforming fluid management from reactive to proactive.

InVera Medical

Received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. The InVera Infusion Device features a 5Fr catheter with a novel helical coil to mechanically prepare the vein wall by disrupting the inner media layer for enhanced infusion of sclerotherapy agents, offering significant improvements in procedural efficiency for physicians, requiring only a single injection of local anesthetic, which supports faster patient recovery.

iota Biosciences

Appointed Michael Woods as CEO, following Michel Maharbiz. Woods brings a strong commitment to the company’s culture of innovation, the highest standards of patient safety and quality, and the continued strengthening of strategic partnerships, and will help the company expand its clinical impact.

NuevoSono

Welcomed LSI Alumni Bill Little to its Board of Directors. Little has dedicated his career to guiding innovative cardiovascular technologies from their initial development stages through successful commercialization and exits, with extensive experience in senior executive positions at Boston Scientific, Bard Peripheral Vascular, Inc., St. Jude Medical, and Abbott Vascular.

Nutromics

Appointed Thomas M. Prescott as Board Chair, bringing deep U.S. medtech commercialization experience as the company enters a pivotal new phase. The appointment comes as the company prepares to open its Series B round and advances toward its planned U.S. commercial launch in 2027.

PAVmed

Appointed Joseph Virgilio as Senior Vice President and Chief Business Officer, Medical Devices, to oversee the development and commercialization of the company’s current and future medical device portfolio. Virgilio brings over 25 years of leadership experience across the medical device industry, with a track record of building and scaling medical technology businesses, advancing products from development through regulatory approval and commercialization, raising public and private capital, and establishing strategic partnerships.

Pulse Biosciences

Announced enrollment of the first patients in its NANOPULSE-AF IDE Pivotal Clinical Study Evaluating nPulse™ Cardiac Catheter System for Atrial Fibrillation at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Devi Nair, MD. The company also appointed LSI Alumni Liane Teplitsky as its new COO to oversee clinical, regulatory, quality, and commercial functions.

Scalpel AI

Welcomed Sean O’Hara as a GTM Operations Advisor. O’Hara brings two decades of experience at Zimmer Biomet and in the OEM world, along with a deep understanding of what it takes to drive meaningful AI transformation in the surgical supply chain.

Sovato

Appointed LSI Alumni Brian Miller, PhD, as its new CEO. Miller brings over 25 years of experience in surgical robotics and digital innovation, most recently as Head of Digital and AI Strategy at Intuitive.

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.