In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive FDA 510(k) clearance, enter new strategic partnerships, appoint new executives, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Received FDA 510(k) clearance for its SuperBall RC system for rotator cuff indications. The SuperBall RC system is based on the company’s SuperBall technology utilized in meniscus repairs and is designed to enable safe, easy fixation of rotator cuff augmentation grafts.
Announced a strategic partnership with Vesica Health, developer of AssureMDx, to enhance bladder cancer diagnostics. Vesica’s AssureMDx utilizes a simple urine sample to assess the presence of specific DNA biomarkers associated with bladder cancer.
Partnered with Medtronic Neurovascular to enhance stroke care across Western Europe via Brainomix’s AI-driven imaging technology and Medtronic’s expertise in neurovascular solutions. The collaboration aims to accelerate stroke diagnosis and improve patient outcomes through optimized treatment pathways.
Announced positive six-month pivotal clinical data on its percutaneous sacral neuromodulation (pSNM) system for treating urgent urinary incontinence. The results demonstrate comparable efficacy when compared to conventional SNM devices.
Teamed up with Gustave Roussy Cancer Institute to advance predictive markers for immune-related adverse events in patients receiving immunotherapy. The partnership aims to improve patient selection for immunotherapy and optimize treatment strategies.
Appointed Jackie Fielding to its Board of Directors. With over 30 years in medical device commercialization, including 18 years at Medtronic, Fielding brings extensive expertise to support Ossiform’s mission of advancing 3D-printed bio-integrative, patient-specific bone implants.
Appointed LSI Alumni Ted Bird as Vice President of Spine Commercial to lead its new U.S. spine division following Demetra’s majority acquisition of GetSet Surgical. Bird will oversee the launch of sterile-packaged spine procedure kits and drive strategic growth in outpatient spine surgery.
Initiated Phase 2 enrollment for its second-generation precision neuromodulation system in early-stage Alzheimer’s disease. The randomized, double-blind study at multiple centers in Italy has enrolled its first patients, with a target of up to 60 patients.
Announced a partnership with the U.S. Air Force to study the use of transcutaneous auricular neurostimulation technology for motion sickness and spatial disorientation. The collaboration explores novel applications for military aviation safety and human performance.
Announced a new collaboration with Beth Israel Deaconess Medical Center (BIDMC) for a study in pulmonary edema detection. The study will assess Strado’s FDA-cleared wearable stethoscope technology for the early detection of pulmonary edema in critically ill patients on mechanical ventilation.
Won the TED 2025 Ideas and Innovations Competition for its Suture-Tight endovascular catheter. The catheter delivers preloaded sutures, ensuring secure attachment of endovascular aortic repair grafts (EVAR/TEVAR) to the aorta during the initial implant or repair procedure.
Appointed Tom Arnold as its Chief Executive Officer to lead its next phase of growth. Arnold brings extensive experience in diabetes technology and will oversee the expansion of the Kaleido insulin pump and automated insulin delivery system.
Celebrated a major milestone as Hoag became the first in the Western U.S. to offer miniaturized robotic-assisted surgery with Virtual Incision’s MIRA Surgical System. This advancement aims to enhance minimally invasive surgical procedures, offering patients reduced recovery times and improved outcomes.
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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