In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funding, enter new partnerships, receive regulatory clearances, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).
Received FDA clearance for the next generation of its KAI 12L AI technology for the Kardia 12L ECG system, expanding its capabilities to 39 cleared cardiac determinations. The update adds five new determinations, further broadening the diagnostic reach of AliveCor’s portable, AI-powered 12-lead ECG technology.
Entered a collaboration with Abbott to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system. The partnership will pair AtaCor’s Atala parasternal EV-ICD lead with Abbott’s investigational ICD platform, aiming to deliver lifesaving defibrillation therapy without placing hardware inside the heart or vasculature, potentially reducing long-term lead-related risks.
Entered a strategic collaboration with Kestra Medical Technologies to expand diagnostic insight for patients prescribed the ASSUREⓇ Wearable Cardioverter Defibrillator. The agreement includes an exclusive license, co-development arrangement, and a $5M equity investment, enabling integration of Biobeat’s FDA-cleared, cuffless 24-hour ambulatory blood pressure monitoring technology into Kestra’s cardiac recovery platform.
Secured a strategic investment from Johnson & Johnson’s JJDC venture arm to support the rollout of its Dexter surgical robot in ambulatory surgery centers (ASCs). The funding builds on Distalmotion’s recent $150M Series G round and advances the company’s strategy to expand access to its modular, ASC-focused soft tissue robotic system across outpatient care settings.
Announced new initiatives as part of their collaboration with NVIDIA to integrate NVIDIA IGX Thor, an NVIDIA Blackwell-powered, enterprise-ready platform, into EndoQuest’s next-generation robotic system. The company also announced that the FDA approved initiation of the final stage of EndoQuest’s pivotal PARADIGM trial, enabling enrollment completion ahead of a planned U.S. De Novo submission.
Announced that the first patients have been enrolled in its BRIDGES U.S. clinical trial evaluating GammaTile for newly diagnosed glioblastoma. The study assesses whether implanting GammaTile at the time of tumor resection, enabling radiation to begin immediately, can improve survival outcomes versus standard postoperative care.
Welcomed Daniel Hawkins as an advisor, adding deep medtech leadership experience spanning cardiovascular devices, surgical robotics, and medical imaging. Hawkins, founder of Shockwave Medical and current CEO of Vista AI, brings a track record of building category-defining technologies and scaling them from early development through commercialization.
Received FDA 510(k) clearance expanding pediatric use of its iotaSOFTⓇ robotic-assisted cochlear implant insertion system to patients four years and older. The clearance broadens access to standardized, controlled electrode array insertion in school-aged children and marks adoption by Cincinnati Children’s Hospital as the first dedicated pediatric center to implement the technology.
Received FDA 510(k) clearance for its Last Inch Assessment™ (LIA) system for lung biopsy procedures. The clearance enables the use of the silicon photonics–based imaging platform to deliver real-time, depth-resolved tissue insight at the point of biopsy, addressing a key gap between nodule navigation and diagnostic confirmation.
Secured commitments to close an oversubscribed $4.1M Seed Prime II funding round, bringing total capital raised to $11.3M. The proceeds will support its first-in-human clinical study in Canada for the Chondrograft™ knee cartilage implant, advance R&D efforts, and lay the groundwork for a future pivotal trial.
Announced that it expects to receive up to $21M in cash proceeds following the acquisition of its strategic holding, Vivasure, by Haemonetics. Orchestra BioMed expects to receive $11M of proceeds in 2026, made up of ~$5M upfront and ~$6M in a first milestone payment, with the remainder of the proceeds expected to be received in future revenue earnouts based on the achievement of certain milestones.
Received medical device registration approval from the Saudi Food and Drug Authority for its pulmonary artery denervation therapy for pulmonary arterial hypertension. This milestone follows the company’s successful CE-MDR certification in Europe and commercialization in the United Arab Emirates in 2025.
Entered a strategic partnership with ATEC, granting ATEC exclusive U.S. commercial rights to market and distribute Theradaptive’s OsteoAdaptⓇ osteoinductive bone graft for spinal fusion. Concurrently, Theradaptive initiated a Series B financing to accelerate the expansion of its proprietary protein-engineering platform across global therapeutic applications.
Appointed Jeff Tyber to its Board of Directors, bringing over 25 years of management, engineering, regulatory, and operational experience. Most recently, Tyber served as CEO and Founder of Tyber Medical, which was acquired by Montagu and subsequently merged with Intech and Resolve Surgical to form Exalta Group.
Received FDA clearance to expand its AI-guided Echo Stewardship Platform across handheld, laptop, and cart-based ultrasound systems. The expanded authorization enables health systems to deploy AI-guided focused cardiac ultrasound (FoCUS) on the devices they already own, with no hardware replacement required.
Announced the close of a $29.5M Series B round backed by health systems including Cedars-Sinai and Intermountain Health, alongside Khosla Ventures and existing investors. With the new financing, the company will build on its FDA-cleared and commercially available cardiac MRI platform by expanding into additional anatomies, including brain, prostate, and spine, once cleared by the FDA.
Raised €14M to accelerate European and U.S. expansion of its AURA 10 PET-CT, the first intraoperative specimen PET-CT system. The funding will support commercial scale-up and strengthen clinical and health-economic evidence as XEOS advances a new paradigm for assessing resection completeness at the point of surgery and reducing re-interventions.
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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