In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, achieve clinical milestones, receive regulatory approvals, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) for its AK-AVS™ aortic valve stenosis ECG-based AI screening software. AK-AVS is an ECG-based AI algorithm intended to aid in the diagnosis of moderate to severe aortic valve stenosis in adult patients 22 years and older, utilizing data derived from 12-lead ECGs obtained during the course of routine care.
Welcomed LSI Alumni Brad Fernald as Vice President, USA. Fernald has built and scaled businesses across neurotechnology and medical software, contributing to more than 20 medical device launches, with a strong track record of turning clinically validated innovation into real-world adoption and impact.
Closed a $2.5M Seed+ financing round led by True Ventures, bringing total capital raised to $4.6M with additional support from investors including Defined VC and Old Line Capital Partners. The financing will support continued product development, regulatory advancement, and preparation for commercialization to advance the company’s technology toward broader clinical adoption.
Received FDA clearance for Dexter in sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection, its fourth overall clearance and second in gynecology. Dexter is a modular, small-format, open surgical robot built for accessibility across hospitals, outpatient departments, and ASCs, using fully wristed, single-use instruments with lower reprocessing needs.
Received FDA 510(k) clearance for its new Hepatoscope-Derived Fat Fraction (HDFF). The feature combines the Quantitative Ultrasound parameters that were already available on the system: ultrasound attenuation and backscattering coefficient, a feature that empowers clinicians to non-invasively estimate intra-hepatic fat at the point of care.
Welcomed Aoife Cameron as its new COO. Cameron brings extensive experience across early-stage medical device startups and life sciences strategy consulting, including launching medical devices, advising companies on clinical and regulatory strategy, and guiding biopharma and pharmaceutical services clients.
Published 3-year clinical results in Endoscopy International Open evaluating partial jejunal diversion created with its magnetic anastomosis technology in patients with obesity and type 2 diabetes or prediabetes. At 36 months, patients demonstrated durable weight loss and glycemic improvement with no device-related serious adverse events, highlighting the delayed-lumen capabilities of the company’s magnetic compression technology.
Granted a new U.S. patent, bringing its total portfolio to 19 patents across four patent families. The company’s VELEX™ system is a patented minimally invasive, non-thermal, non-tumescent endovascular device designed to enhance sclerotherapy procedures for patients with chronic venous insufficiency.
Closed an oversubscribed $7.2M Series A to scale its orthopedic bracing technology across the U.S., with funds going toward commercialization, manufacturing expansion, and clinical validation. The company combines biomechanics, additive manufacturing, and patient-focused design in products like its Ascender Knee Brace for osteoarthritis.
Received UKCA certification for its Lupin® Robotic System, authorizing commercialization of the system in Great Britain. The supervised automated robotic system enables precise and repeatable minimally invasive tooth preparation for porcelain laminate veneers, supporting high-quality aesthetic and clinical outcomes for patients.
Completed its first-in-human feasibility study, demonstrating the ability to record key nerve-related biosignals from 16 peripheral nerves in eight chronic pain patients across multiple anatomical targets. Conducted in collaboration with physicians at Hospital Punta Pacifica in Panama, the study showed the company’s technology could record both evoked compound action potentials (ECAPs) and muscle potentials using neurostimulation leads.
Secured $110M in new capital to support the U.S. commercial expansion of its Genio implantable therapy for obstructive sleep apnea (OSA). The financing includes $95M in equity funding and an expected $15M second tranche from the European Investment Bank loan.
Completed the first Connexus® BCI implantation in its FDA-approved Connect-One clinical study at University of Michigan Health. The Connexus BCI is designed to record, decode, and translate neural signals through an implantable high-density microelectrode array that gathers data from the brain and sends it to a discrete transceiver in the chest, where it is then transmitted wirelessly through the skin to an external receiver.
Completed enrollment and data collection for the first 15 patients in its Investigational Device Exemption (IDE) Pilot Study at Louisiana State University Health Shreveport. The study is designed to collect fetal pulse oximetry data using its investigational transvaginal sensor, which is positioned on the fetus's cheek during active labor.
Received FDA 510(k) clearance for its UNEEG EpiSight System, designed to enable ultra-long-term, 24/7 EEG monitoring in real-world settings. The minimally invasive implant captures continuous brain activity data over extended periods and, combined with advanced analytics, supports improved seizure tracking, objective seizure identification, and optimized clinical decision-making for epilepsy patients.
Closed an €30M oversubscribed Series D round, welcoming ENEA Tech and Biomedical as a strategic new investor. The proceeds will be used to advance the development and clinical adoption of the Heron® lead, its flagship product for spinal cord stimulation.
Published its BrIMA study in JAMA Surgery, demonstrating that the company’s AURA 10® PET-CT system improved surgeons’ ability to identify and address positive margins during breast-conserving surgery. The prospective multicenter trial showed intraoperative success rates increased from 83.3% to 95.2% in invasive ductal carcinoma patients and from 76.4% to 91.9% across all breast cancer subtypes, with no device-related adverse events reported.
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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