In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, get acquired, secure funding, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Announced a multi-year agreement with Specialized Medical, combining Specialized Medical’s resilient hardware connectivity and robust operations capabilities with the company’s best-in-class ECG analytics. Under this partnership, the company’s FDA-cleared Class II SaMD, AccurECG™ 2.0, is actively powering Specialized Medical’s state-of-the-art cardiac monitoring operations, which currently serve more than 20 clinics, medical practices, and hospitals across four states.
Granted a new patent in the UK for an innovation adjacent to its core device, reflecting the company’s broader approach to technology development. The company aims to revolutionize how first responders treat violence-related catastrophic hemorrhage, with a focus on knife crime.
Received the CE mark for its Kardia 12L electrocardiogram (ECG) system. The system, powered by AI, leverages the KAI 12L deep neural network machine learning AI model trained on more than 1M recorded ECGs to enable faster, easier detection of 35 cardiac determinations, including acute myocardial infarction and the most common types of cardiac ischemia.
Received FDA clearance for its ExaStimⓇ Stimulation System, marking a key milestone in the company’s commercial strategy. The ExaStim Stimulation System delivers personalized transcutaneous spinal cord stimulation, non-invasively, supporting functional neurorehabilitation for patients with paralysis due to spinal cord injury.
Announced the successful treatment of its first patient at UChicago Medicine for the BREATHE-3 Study. The trial, led by Dr. D. Kyle Hogarth, is evaluating the safety and efficacy of the Apreo BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related lung hyperinflation in patients who continue to have difficulty breathing despite optimal medical management.
Received FDA PCCP clearance for its AI algorithms that automatically convert DICOM data into highly accurate patient-specific 3D models, becoming the first AI automated segmentation company to do so. The clearance formally establishes a pre-approved Quality process for improving its algorithms, without requiring a new 510(k) regulatory process for each new version.
Announced FDA clearance of its Cala kIQⓇ Plus system, the next-generation of its wearable neurostimulation device for action hand tremor in essential tremor (ET) and Parkinson's disease. Cala kIQ Plus is the latest advancement in TAPSⓇ technology, introducing new therapy modes and adaptive calibration designed to optimize tremor relief and personalize treatment, providing patients with an intuitive experience whenever tremor control is needed.
Announced that its Founder & CEO, and LSI Alumni, Moises Barbera Ramos, was recognized in the Europe 2026 30U30 in the Science and Healthcare category. The company aims to redefine orthopedic precision through mixed reality and artificial intelligence, empowering surgeons to operate with clarity, confidence, and control while reducing X-rays and operating time.
Appointed Rupa Basu as the Chairperson of the Board to serve as a strategic guide for the company as the organization advances toward its first-in-human clinical trial and prepares for U.S. market entry. Basu brings over 30 years of deep experience in fundraising, market entry, and leading multidisciplinary teams, with a focus on driving sustainable growth and long-term shareholder value.
Awarded over $110K at the Rice Business Plan Competition. The awards included the 3rd Place Investment Prize ($50K), the Spirit of Entrepreneurship Award ($25K), an investment prize ($25K), the Company Showcase Award ($1K), the Baker Botts in-kind legal services award ($10K), and a participation grant.
Commercially launched the Robotic Suture in the U.S., the first suture purpose-built for its Symani surgical system. Robotic Suture features a shorter suture length and needle enhancements tailored to robotic techniques, designed to improve handling, streamline workflow, and provide consistent performance during robotic anastomosis.
Welcomed Brian Napack as an Executive Advisor and Limited Partner. Napack brings an extraordinary track record of executive leadership and an exceptional ability to guide complex, knowledge-driven organizations through transformation to sustainable growth, previously holding positions as CEO of John Wiley and Sons and President of Macmillan.
Closed an $8M financing round led by Ambit Health Ventures, with participation from Emmeline Ventures, Disrupt Health Impact Fund, and existing investors Esplanade Ventures and Portfolia. The round will help the company scale manufacturing, expand clinical research, and broaden the commercialization of its FDA-cleared OsteoboostⓇ, designed to treat low bone density.
Announced that it has entered into a definitive agreement to be acquired by Stereotaxis, a global leader in surgical robotics for minimally invasive endovascular intervention. The acquisition will combine the company’s mechanical robotic system with Stereotaxis’ magnetic navigation technology to create a highly differentiated, fully robotic solution for endovascular surgery.
Published peer-reviewed interim data from its ongoing multicenter pivotal study, published in Updates In Surgery, reporting six-month outcomes from the first 25 of 94 patients following breast-conserving surgery and adjuvant whole-breast radiotherapy. The interim analysis showed no device-related adverse events, 100% completion of whole-breast radiotherapy without permanent interruption, no MRI or ultrasound interference with oncologic surveillance, 88% good-to-excellent cosmetic outcomes, and statistically significant improvements in breast satisfaction and cancer-related distress.
Published the six-month results of its first in-man cohort in the American Heart Association Circulation: Cardiovascular Interventions for the AMEND system, a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach aimed to affect selective anteroposterior dimensional reduction, improving leaflet coaptation, and reducing mitral regurgitation (MR). In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the six-month follow-up period.
Published the results of its multicenter ADOPT clinical trial in Clinical Chemistry. The results from the study showed 94.5% overall first-stick success rate, 0.3% hemolysis rate, 0.6% adverse event rate, and 90% of patients reported less or similar pain to a manual draw, with 82% who would prefer AlettaⓇ or had no preference for their next visit.
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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