In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, receive regulatory approvals, launch partnerships, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Received Investigational Medical Device Dossier (IMDD) approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to initiate the first chronic implantation study of the company's fully implantable wireless optical-link ECoG BCI in patients with ALS. The approval marks an important milestone, transitioning the company from intra-operative testing into chronic clinical investigation and representing the first long-term use of the company's implantable platform in humans.
Entered into a partnership with Siemens Healthineers to advance the MRI-guided robotic neurosurgery ecosystem. The collaboration agreement supports integration of the company’s compact, MRI-compatible robotic stereotactic neurosurgery system and associated workflow with the market-leading Siemens Healthineers’ MAGNETOM MRI scanners.
Received FDA 510(k) clearance for a new Contractility Frequency Map feature as an enhancement to the existing Atmo Gas Capsule System. This feature is a visualization of capsule movement caused by gastrointestinal pressures and contractions throughout the regions of the GI tract that enables clinicians to see the different rates and intensities of contractile activity in the stomach, small bowel, and colon.
Received FDA BDD for the lateral Artimis® Meniscus Prosthesis. The Artimis Meniscus Prosthesis is a biomimicking polymer meniscus replacement inserted through minimally invasive keyhole surgery, designed to restore knee mechanics and provide rapid pain relief.
Received FDA BDD for its Cardiac Performance Simulation Engine and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheterization-comparable hemodynamic assessment using consumer smartwatches and standard blood pressure cuffs in clinical and home settings under physician supervision.
Received CE mark approval and Singapore HSA certification for its Sentire® Surgical System, granting it access to both the European and Asia-Pacific markets. The Sentire Surgical System is a high-end surgical robotic platform that combines clinical workflows with integrated engineering, software, and imaging technologies.
Entered into a licensing and collaboration agreement with Duke Health and Mayo Clinic to develop Gynethotics™ Recovery, personalized intravaginal devices for post-surgical pelvic recovery following reconstructive surgery. This collaboration brings together clinical expertise and the company’s scalable precision care platform that aims to redefine post-surgical healing and meaningfully improve outcomes and quality of life.
Received a grant from the Israel Innovation Authority under the Applied Research in Industry Track. The grant supports the company’s expansion from aortic repair into Structural Heart, building on its core anchoring and fixation platform.
Announced that technologies, inventions, and derivative product families associated with founder Howard J. Leonhardt and affiliated innovation programs have now contributed to the treatment of more than 1M patients worldwide. The milestone reflects over four decades of innovation spanning cardiovascular devices, regenerative medicine, bioelectric stimulation, intravascular lung, radiation catheters, structural heart technologies, catheter systems, stent grafts, percutaneous heart valves, and biologics therapies.
Received a new undisclosed investment co-led by ZEISS Ventures and M2care. The funding will support the company’s progression toward clinical validation and commercial readiness for its personalized retinal laser treatment.
Raised €4M in an oversubscribed funding round backed by private investors. The company is developing a brain-computer interface that interfaces directly with the visual cortex to restore functional vision in patients who cannot benefit from retinal or optic nerve-based therapies.
Received an undisclosed investment led by Epic Angels. The company is developing the Sylvee device, an AI-enabled wearable designed to continuously monitor lung function and prevent COPD attacks.
Completed the 5000th case with its TMINI® Miniature Robotic System for total knee (TKA) procedures. The case, completed by Dr. John Tiberi of Cedars-Sinai Orthopedics in Los Angeles, CA, comes just one year after its 1000th case.
Appointed LSI Alumni Rick Geoffrion as Chairman of the Board. Geoffrion brings more than 35 years of medical technology leadership experience, including over 30 years in the cardiovascular space, spanning interventional cardiology, circulatory support, structural heart, and medical device commercialization, raising more than $200M in venture capital over the course of his career.
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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