In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funds, receive 510(k) clearances, launch clinical studies, and much more on the road to LSI Europe ‘25 in London (September 7-11).
Received FDA approval to initiate the MOCA-II IDE pivotal trial evaluating its CoFI system for real-time detection of microvascular obstruction (MVO) during primary PCI procedures. The study will enroll over 200 STEMI patients in the U.S. and Europe, advancing efforts to address a major unmet need in heart attack care.
Appointed Eli Aharoni as CTO and Vice President of R&D to lead the development of its next-generation ophthalmic implants. Aharoni brings decades of experience in vision restoration technologies, including co-developing the SING IMT for advanced macular degeneration at VisionCare (now Samsara Vision).
Announced the world’s first implantation in a patient of its Left Ventricular Assist System (LVAS), the first heart pump based on breakthrough wave membrane technology. The device preserves the natural heartbeat and pulse, aiming to reduce complications and improve outcomes for patients with advanced heart failure.
Appointed Dr. Robert Pelberg as Senior Vice President of Medical Affairs to lead the company’s clinical and research strategies, as well as clinical operations quality efforts. His expertise in cardiac CT will support Elucid’s mission to deliver histology-validated, AI-driven tools for personalized cardiovascular care.
Secured a $2M investment from the Government of Canada to enhance manufacturing processes and accelerate global commercialization of its AI-driven postoperative care platform. Funding will support FluidAI’s Stream™ Care and Origin™ technologies, designed to improve outcomes and reduce hospital stays through predictive analytics and real-time sensing.
Secured a second Innovate UK Smart grant, receiving £500K to advance development of the Yacoub Heart ValveⓇ, which uses an intricate scaffold designed to create a brand-new heart valve in place of a damaged, diseased, or congenitally defective valve. The company is now preparing for an FDA IDE application and a 50-patient clinical trial to pave the way for global adoption.
Received FDA 510(k) clearance for the HYPERSNAPⓇ Surgical System, the first intraoperative platform to combine hyperspectral imaging with AI-powered analytics for real-time surgical decision support. The system delivers real-time, quantitative tissue oxygenation maps to enhance precision and safety during open and minimally invasive procedures.
Was appointed CEO of Like Minded Labs, the media technology company he co-founded to empower creators through enhanced digital communication. His leadership marks a new phase of growth for the company, coinciding with the board appointment of former Disney CEO Bob Chapek.
Shared plans to be acquired by Alcon, advancing the global reach of its photobiomodulation (PBM) technology for dry age-related macular degeneration AMD. The deal strengthens LumiThera’s mission to deliver non-invasive, vision-improving treatment to millions affected by early and intermediate stages of the disease.
Launched a multicenter clinical study to evaluate its XR90 augmented reality platform for soft tissue biopsy procedures. The study will assess how XR90 can enhance standard imaging guidance by improving procedural efficiency and clinician workflow.
Received FDA 510(k) clearance for Focalist, its handheld robotic system designed to improve ultrasound-guided needle placement. The platform aims to bring consistency and efficiency to high-volume procedures like biopsies and vascular access, starting with a focus on urology.
Received Health Canada approval to initiate its first-in-human clinical trial of the Chondrograft™ implant for cartilage defects in the knee. The early feasibility study will evaluate safety and performance outcomes as the company prepares for a larger pivotal North American study.
Announced a partnership with Neurowave to distribute its MOVEⓇ-C cervical disc prosthesis in Portugal. The collaboration will expand access to NGMedical’s motion-preserving spine technology through Neurowave’s established regional network.
Appointed Sagi Moran as Vice President of Operations to support the production scale-up of ArtiFasciaⓇ and clinical advancement of ArtiFixⓇ. Moran brings over 20 years of experience in scaling medtech operations, supply chain management, and process optimization.
Initiated a Phase 1b clinical trial of PTM-101, its localized, long-lasting, high-dose chemotherapy patch for pancreatic cancer. The study follows promising early results and will assess higher doses in combination with standard therapy across multiple U.S. cancer centers.
Closed a $4.5M funding extension round to support the U.S. launch of BLOOM⁴³, its wearable prehabilitation device for breast surgery. The round strengthens momentum ahead of Series A and broadens the development of its surgical care platform.
Appointed LSI Alumni David Carey as CEO to lead the expansion of its HummingbirdⓇ TTS system, which enables in-office pediatric ear tube procedures without general anesthesia. The leadership transition supports the company’s strategy to scale safer, more family-centered ENT care.
Received FDA 510(k) clearance for its LibAirty™ Airway Clearance System, the first solution to synchronize guided breathing with targeted chest compressions for at-home respiratory care. The clearance supports U.S. launch plans and the company’s expansion with a new headquarters in Jersey City.
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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