In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni launch new products, secure regulatory approvals, appoint new executives, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Completed enrollment of an initial cohort of ten patients in its EMBO-02 clinical study of NeoCast to treat chronic subdural hematoma (cSDH). Neocast is a solvent-free, non-adhesive liquid embolic agent designed for effective deep distal penetration.
Announced the launch of its most recent product, Serranator SL-PRO PTA Serration Balloon Catheter. The Serranator SL-PRO is specifically designed for pedal interventions and challenging-to-cross tibial disease.
Shared the initial results of its pilot clinical study evaluating the eShunt System for elderly patients with normal pressure hydrocephalus (NPH). The data supports the system’s potential as a minimally invasive alternative to traditional shunt surgery.
Received FDA 510(k) clearance for its GYDER Hip System. The system is the world’s first commercially available pin-less/non-invasive, imageless solution for accurately positioning the acetabular cup during anterior hip arthroplasty.
Appointed LSI Alumni Adam Szaronos as Chief Executive Officer to lead the company’s next phase of growth. Szaronos, an ophthalmic industry executive, brings extensive experience in commercial strategy and medical device innovation.
Appointed Donghee Kim as Chief Executive Officer. Leveraging her 20 years of experience at multinational medtech companies, Kim is expected to drive strategic partnerships and global growth initiatives.
Introduced its new continuous 24-hour EEG monitoring system. The system is designed for comprehensive brain activity monitoring and analysis and is intended to provide deeper clinical insights beyond that of traditional EEGs.
Secured FDA IDE approval to begin a U.S. pivotal trial for its adaptive deep brain stimulation (DBS) system. The study will evaluate the system’s performance relative to conventional DBS in subjects with advanced Parkinson’s disease.
Appointed LSI Alumni Shane Brown as Chief Executive Officer to lead the company’s expansion in the healthcare staffing industry. Under Brown’s leadership, NurseIO will further develop its technology-powered staffing solutions and expand its network of healthcare professionals and facilities in the United States.
Appointed Christopher Cleary, former Medtronic SVP of Corporate Development, to its Board of Directors. Cleary brings extensive experience in M&As and strategic partnerships, including his role in shaping Orchestra BioMed’s collaboration with Medtronic for atrioventricular interval modulation (AVIM) therapy.
Joined the NVIDIA Inception Program to advance AI-powered surgical leak detection. This collaboration will provide Qaelon with access to cutting-edge resources, accelerating the development of its real-time, objective performance indicator (OPI) for surgical leaks.
Received a key U.S. patent for its regenerative bone adhesive technology. The patent strengthens RevBio’s intellectual property portfolio as it advances commercialization efforts for its novel bone repair solutions.
Received positive FDA feedback on the Phase III trial design for 99mTc-maraciclatide, its imaging agent for diagnosing superficial peritoneal endometriosis. With Fast Track Designation granted, the company is finalizing plans to advance its non-invasive diagnostic solution.
Received FDA Breakthrough Device Designation for its MicroAngioscope, the first device enabling direct intracranial angioscopy. Already in use in Canada, this technology aims to transform stroke diagnosis and treatment by providing real-time, high-definition imaging inside brain blood vessels.
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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