In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni announce an acquisition, appoint new executives, close funds, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).
Announced the availability of its B-Right AI Platform through GE HealthCare’s Voluson™ Solution Store, bringing AI-driven support directly into routine prenatal ultrasound workflows. The collaboration aims to improve early detection of congenital defects, reduce diagnostic uncertainty, and expand access to expert-level prenatal care for Voluson ultrasound users.
Medtronic announced it will exercise its option to acquire CathWorks, a deal valued at up to $585M that follows the companies’ 2022 strategic partnership and co-promotion agreement for the CathWorks FFRangioⓇ System in the U.S., Europe, and Japan, where it is commercially available. CathWorks also announced executive leadership promotions, naming Sarita Monico as Chief Marketing Officer, Fabian Ngo as Chief Strategy Officer, and Natalie Sickler as Chief Business Officer.
Was launched by LSI Alumni Jeff Cambra as a firm designed to support and scale the next generation of transformative companies, technologies, and strategic partnerships. The firm will work closely with early- and growth-stage companies to drive marketing strategy, fundraising, early commercialization, strategic planning, board governance, and market expansion across the U.S. and Europe.
Galvanize Therapeutics Founder and former CEO and President Jonathan Waldstreicher, MD, announced he is stepping down after 12 years leading the company and will become CEO of a new stealth startup based in Central New Jersey. He also shared that he has joined Pierpoint Capital as an Operating Partner, where he will support the firm’s portfolio of healthcare technology companies.
Announced completion of patient enrollment in the SPIRARE II pivotal clinical trial evaluating the Vertex™ Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism. The prospective, single-arm, multicenter study enrolled 123 patients across 23 sites in Europe and the U.S. and is designed to evaluate safety, right heart function, and clinical improvement through 30 days post-procedure.
Reported the successful first-in-human clinical use of its Last Inch Assessment™ system at the University of Chicago Medical Center following FDA 510(k) clearance. The integrated imaging and biopsy device provides real-time, depth-resolved imaging to help physicians confirm that tissue is collected from the intended target during lung biopsy procedures.
Announced the release of two new versions of MAGENTIQ-COLO™, its AI-powered colonoscopy platform incorporating computer-aided detection for real-time polyp detection and computer-aided diagnosis capabilities. The U.S. version adds an AI-based endoscopic tool detection capability, while the CE-marked version adds AI-based procedural quality metrics and workflow-aware features.
Announced a patent allowance for Sleep WISP™, a comfortable headband designed for at-home use, securing new intellectual property related to monitoring glymphatic clearance and enhancing glymphatic flow during sleep. The patent covers the ability to register a Glymphatic Clearance Capacity and improve glymphatic flow through Sleep WISP stimulation, supporting the company’s development of the technology as both a diagnostic and therapeutic tool for next-generation brain care.
Published first-in-human study results in Nature Biotechnology, demonstrating real-time monitoring of the antibiotic vancomycin using its lab-on-a-patch. The world-first milestone marks a clinically feasible demonstration of real-time drug monitoring in humans and an important step toward expanding continuous monitoring beyond glucose and into hospitals, clinical trials, and broader healthcare settings.
Enrolled the first participant in Empower BP, a global pivotal study evaluating the safety and effectiveness of its ARC-IMⓇ System for managing symptomatic blood pressure instability in people with chronic spinal cord injury. The study marks the first global pivotal trial of the investigational implantable spinal cord stimulation platform and is expected to enroll participants across 20 leading neurorehabilitation and neurosurgical research centers in the U.S., Canada, France, Germany, Spain, and the UK.
Appointed John Sperzel as Chief Executive Officer, succeeding co-founder Connor Campbell, who will remain on the Board of Directors. The leadership transition comes as Osler shifts from an R&D-led organization toward commercial execution, advancing the Osler OriginⓇ platform through remaining regulatory processes and market launch.
Received conditional Human Research Ethics Committee approval to begin a world-first human study of its Transcatheter Aortic Recoil Repair (TARR™) device in patients with acute decompensated heart failure. The pilot study is expected to begin in early 2026 at Monash Health’s Victorian Heart Hospital as the company progresses the device through a staged clinical and regulatory pathway.
Closed its fifth fund with $330M in committed capital, exceeding its $300M target, to continue investing in innovative biotechnology, medical technology, and digitally enabled healthcare companies addressing significant unmet medical needs. The firm also announced the promotions of Dennis McWilliams and Omar Khalil to Managing Directors.
Completed the first close of its $6M Series A preferred stock financing led by Harbright Ventures, with Founding Partner Robert Ross joining the Board of Directors. The funding will support key 2026 milestones, including securing FDA approval for a U.S.-based peripheral venous pivotal study and conducting a first-in-human study for pulmonary embolism treatment.
Received FDA Breakthrough Device Designation, marking an important step in the company’s mission to improve access to deep vein thrombosis diagnostics in the U.S. The designation enables enhanced collaboration with the FDA as the company progresses toward U.S. regulatory submission.
Announced that the FDA has approved its Investigational New Drug (IND) application for LGW16-03, its first nerve-specific fluorescent imaging agent, enabling the initiation of first-in-human clinical studies to evaluate safety and intraoperative performance in surgical settings. LGW16-03 is designed to selectively bind peripheral nerves and emit a near-infrared fluorescent signal, allowing surgeons to visualize critical nerve structures in real time during surgery.
Received an Innovative Technology contract from Vizient for its Pro-X1Ⓡ Trochanteric Nail following review by hospital experts who serve on one of Vizient's client-led councils. The contract signals to Vizient clients the technology’s potential to improve clinical care and patient outcomes by enhancing fixation stability in compromised bone.
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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