In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, secure funding, launch partnerships, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Received FDA 510(k) clearance for Avatar Medical Vision, its software platform for instant 3D medical image processing, review, and surgical planning, enabling commercialization in the U.S. This clearance also establishes compatibility with the Barco Eonis 3D glasses-free display, forming the foundation of Eonis Vision, a joint solution that aims to bring clinicians and patients together around a shared, real-time view of anatomy during consultations.
Raised an oversubscribed $55M Series A led by C.P. Group Innovation, with participation from Alumni Ventures, the Stanford President’s Venture Fund, Hillhouse Investment, and Gaorong Ventures. The company will use the funds to expand global clinical trials, advance U.S. regulatory approval of its implantable brain-computer interfaces, and build a GMP facility for large-scale production.
Appointed Jeff Barone as its VP of Sales, U.S., to lead U.S. commercial strategy and execution. Barone brings an extensive track record of executive leadership across imaging, medtech, minimally invasive surgical technologies, and robotic platforms.
Announced a strategic alliance to jointly develop a next-generation multimodal workflow for the early detection and risk stratification of Alzheimer's disease. The collaboration will combine Vitazi.ai's non-invasive, AI-driven retinal imaging analytics with Circular Genomics' proprietary circRNA biomarker data, leveraging shared algorithmic and machine learning workflows to deliver intelligent, accurate early detection of Alzheimer’s and risk stratification.
Successfully completed Phase 1 of its MOCA II FDA Pivotal Trial and enrolled the first patients for Phase 2 of the trial while simultaneously gaining approval to enroll patients in its parallel flagship clinical trial, the novel randomized REVITALISE trial. The company also welcomed Dr. Rick Kuntz to its Board of Directors and appointed LSI Alumni Dr. Pedro Eerdmans as VP Clinical.
Announced that the first participant in the University of Washington’s NIH-funded clinical trial of the Brain Interchange™ BCI system has successfully controlled a computer through thought alone, including a functional demonstration of the video game Pong, using the implanted device and cortical electrodes placed to support his motor recovery after stroke. This is the first reported instance worldwide in which a single fully implanted, wireless BCI system has demonstrated both brain stimulation for therapeutic stroke rehabilitation enhancement and thought-based computer control in the same patient using identical hardware.
Announced a research collaboration with Mayo Clinic to evaluate how next-generation, non-invasive diagnostics may transform the identification and management of pulmonary hypertension. The collaboration will pair the FDA-cleared CorVista-PH test, part of the CorVista System, with Mayo Clinic’s expertise in cardiovascular research and pulmonary vascular disease to determine whether the CorVista-PH test can meaningfully improve how physicians identify and evaluate pulmonary hypertension earlier in the patient journey.
Announced a strategic collaboration to develop a continuous surgical data ecosystem spanning the operating room through recovery, with a focus on addressing anastomotic leaks in gastrointestinal surgery. The partnership combines Qaelon’s intraoperative leak detection platform with FluidAI’s established post-operative monitoring and intelligence ecosystem, and aims to create a unified framework linking intraoperative data with post-operative healing to improve patient outcomes and reduce complications.
Closed an oversubscribed $23M Series A financing round led by Heal Capital, with participation from Angelini Ventures, IP Group, Daycrest, and follow-on investment from Heran Partners, Redalpine, LifeX Ventures, and Zeiss Ventures. The company plans to use the funds to accelerate commercial deployment of its Hyperspectral Intelligence® platform, expand clinical adoption, and advance next-generation hyperspectral sensing technology in partnership with Imec.
Raised $8.4M in seed funding to accelerate the launch of its flagship Skylight™ platform, a projection-based clinical guidance platform that gives doctors a "heads-up display" of a patient's internal anatomy, shown directly on the body. The raise was led by Wing 2 Wing Ventures, alongside investment from the National Science Foundation (NSF), National Cancer Institute, National Institute on Aging, Elderberry Ventures, Soma Capital, DRF, and other leading venture partners.
Received HSA regulatory approval for its CLiKX®, the world’s first robotic handheld ear tube surgery device. Unlike current surgeries, CLiKX aims to reduce the need for general anesthesia and the surgical microscope, moving surgeries out of the operating room to an outpatient setting like a clinic or procedure room.
Secured AU$3M in non-dilutive funding through the Australian Government's Cooperative Research Centres (CRC) Projects Round 18, as part of a total project value of AU$11.2M. The funding will support the development of a world-first sepsis management microneedle patch capable of real-time, multi-analyte sensing with sensor design accelerated by cutting-edge robotics.
Granted a second FDA BDD for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. Together, the two BDDs for AVIM Therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk, as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT Global Pivotal Trial, which the company is conducting in collaboration with Medtronic.
Appointed Stephen N. Oesterle, MD, to its Board of Directors. Dr. Oesterle is a highly respected leader in the medtech and life sciences industry, with decades of experience spanning clinical medicine, corporate strategy, and venture investing, previously serving as SVP for Medicine and Technology at Medtronic and was a member of the company’s Executive Committee for 14 years, where he helped guide long-term innovation strategy and corporate investments.
Received FDA 510(k) clearance for its Knee+ NexSight. Knee+ NexSight projects a virtual screen into the surgeon’s field of view and integrates voice command, requiring no robot, dedicated console, or single-use disposables to reduce capital investment, operating costs, and environmental impact.
Initiated the full commercial launch of the InSet™ I-135RFX Humeral Stem. The commencement of full launch follows a successful limited market release and receipt of additional FDA 510(k) clearance for an expanded set of fracture indications, enabling the InSet I-135RFX to now be utilized in all primary, revision, and fracture total shoulder arthroplasty procedures.
Granted FDA approval to initiate the pivotal Phase 3 clinical trial evaluating the OASIS Study, evaluating its OsteoAdapt® SP for bone regeneration in spinal fusion procedures. OsteoAdapt SP, powered by the proprietary AMP2™ rhBMP-2 variant, is designed to promote targeted, sustained bone growth while minimizing off-target effects and improving the safety and efficacy of current graft materials.
Announced completion of the first commercial cases in the U.S. with the Vena MicroAngioscope™ system, led by Dr. Peter Kan and Dr. Christopher C. Young at The University of Texas Medical Branch. The Vena MicroAngioscope system uses a small camera to provide physicians with a live, full-color view from inside the vasculature, allowing physicians to directly image complex lesions and tailor treatment decisions, such as stent choice and stent-vessel interaction, in real time.
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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