The Weekly Recap 11/14/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure over $264M in new funding, announce regulatory clearances, enter new partnerships, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

Augmedics

Received FDA 510(k) clearance for X2™, its next-generation augmented reality (AR) surgical headset for use with the xvision Spine System^Ⓡ. Purpose-built for the operating room, X2 enhances visualization, ergonomics, and performance for spine procedures.

Cern

Partnered with HITLAB to advance its light-based, non-drug treatment for recurrent vaginal infections using the Cern Device™, a novel at-home therapy. The collaboration will support validation efforts ahead of FDA review, focusing on usability, safety, and digital health integration.

Clairity

Raised $43M in Series B funding to commercialize Clairity Breast, the first FDA-authorized AI platform that predicts five-year breast cancer risk from a standard mammogram. The financing will also support development of Clairity Breast 3D and Clairity Heart, expanding its predictive imaging platform into cardiovascular disease.

Cognito Therapeutics

Launched the Brain Health Collaboratory with WVU Rockefeller Neuroscience Institute to accelerate real-world adoption of non-drug neurotherapies. The initiative integrates the Spectris device into clinical care to advance treatment for neurodegenerative disease through adaptive, data-driven workflows.

Cornerstone Robotics

Raised $200M in an oversubscribed round to scale global commercialization of the Sentire surgical robot. The company’s autonomous endoscopic robotic surgery platform is designed to ensure consistent, precise movements, minimizing variability and optimizing outcomes.

EBR Systems

Announced that it enrolled the first patients in the WiSE-UP study to evaluate its FDA-approved wireless CRT system. The leadless device delivers left ventricular pacing and works seamlessly with existing pacemakers, defibrillators, or CRT devices that provide right ventricular pacing.

Galvanize Therapeutics

Announced the publication of promising six-month results from the AFFINITY trial evaluating Aliya pulsed electric field (PEF) ablation for lung tumors. The study saw high local control rates of ablated tumors, with data suggesting that Aliya may also trigger systemic immune activation.

Imeka

Received 510(k) clearance for ANDI 2.0, the new version of its flagship software that now combines brain microstructural and volumetric analysis in a single platform. The update aims to position ANDI 2.0 as a true one-stop shop for a smoother, more streamlined workflow.

INBRAIN Neuroelectronics

Entered a strategic collaboration with Microsoft to drive the implementation of agentic artificial intelligence (Agentic AI). The partnership aims to advance real-time precision neurology and the development of next-generation BCI therapeutics for neurological and psychiatric disorders.

Luminoah

Won $50K at the Pediatric Healthcare Innovation Summit pitch competition, funded by the FDA Pediatric Device Innovation Consortium. The company is developing a wearable enteral nutrition delivery system that combines durable medical equipment, smart nutrition pouches, and remote patient monitoring.

Nanochon

Appointed Dr. Kurt Jacobus, orthopedic entrepreneur, engineer, and investor, to its Board of Directors. With leadership experience at MedShape, restor3d, and Vertera Spine, Dr. Jacobus brings deep expertise in 3D printing, biomaterials, and scaling medical device companies to exit points.

NextSense

Raised a $16M Series A led by Ascension Ventures to launch Smartbuds, the first truly wireless consumer EEG earbuds. Launching in Q4 2025, Smartbuds aim to deliver clinically accurate sleep tracking while helping users unlock deeper, more restorative rest through auditory stimulation.

Nyxoah

Closed a series of financings that amount to up to approximately $77 million in proceeds. The financing includes a €17 million private placement of equity, a U.S. $5.6 million registered direct offering, combined with a convertible bond financing of up to €45 million. The company’s Genio system is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for Obstructive Sleep Apnea.

PRECISIS

Received FDA IDE approval to begin its pivotal EASEE4US trial, evaluating the EASEE^Ⓡ system as a minimally invasive neuromodulation therapy for drug-resistant focal epilepsy. Already CE-marked and in use across Europe, EASEE uses epicranial stimulation to fill the gap between medication and invasive surgery.

Quality Means Business

Raised a $2M seed round to launch QualiVerse^Ⓡ, its AI-powered Regulatory Intelligence Engine. The platform is intended to help medical device innovators achieve compliance, accelerate new product development, and scale safely to market.

Rhaeos

Won $25K at the Pediatric Healthcare Innovation Summit pitch competition, funded by the FDA Pediatric Device Innovation Consortium. Rhaeos is developing FlowSense^Ⓡ, a platform technology and a noninvasive wireless, wearable skin patch that can assess and monitor fluid flow subdermally throughout the body.

Samay

Secured its second patent allowance in Japan and its first in Israel, bringing its total to fifteen granted patents. These global protections strengthen the company’s position as it advances its Sylvee wearable chest sensor.

Sentante

Announced the completion of a first-of-its-kind remote stroke procedure in Scotland using its robotic platform. The company says the completed cases demonstrate its technology’s ability to save the lives and prognoses of patients suffering stroke episodes in remote settings.

Surgical Automations

Announced the closing of its $3.4M oversubscribed seed round co-led by Intuitive Surgical founder Dr. Fred Moll and TurboStart. The company is developing the Vāsuki Robotic System, a next-generation platform for upper and lower GI diagnostic and interventional procedures.

THINK Surgical

Appointed Josh DeRienzis as Chief Legal Officer and Board Secretary. He brings over 25 years of experience advising senior management and Boards of Directors in a variety of industries on critical legal and strategic matters to support THINK Surgical’s growth in orthopedic robotics.

VenstraMedical

Received a strategic investment from Highcroft Capital to advance its next-generation percutaneous ventricular assist device. The low-profile, full-flow cardiac support system is designed to provide complete ventricular unloading in critically ill cardiac patients.

ViTAA Medical Solutions

Received FDA 510(k) clearance for AiORTA™ Plan, its fully automated preoperative planning solution for aortic surgery. The milestone marks the first step in the company’s broader platform for hyper-precise, end-to-end vascular care.

XCath

Successfully completed the first-in-human use of its EVR endovascular robotic system to treat brain aneurysms. With these procedures, XCath’s EVR becomes the only endovascular robotic system currently in development to achieve intracranial navigation and neurointerventional treatment.

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.