The Weekly Recap 4/3/26: 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 receive regulatory approvals, appoint new executives, secure funding, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

Anumana

Received FDA 510(k) clearance for its ECG-AI pulmonary hypertension (PH) algorithm for use with standard 12-lead electrocardiograms, the first of its kind cleared for clinical use. The algorithm, which previously received FDA Breakthrough Device Designation, helps clinicians identify patients with an elevated mean pulmonary arterial pressure in adults presenting with dyspnea, broadening the company’s portfolio of AI-enabled, workflow-integrated solutions.

CathWorks

Published the one-year clinical outcomes of the ALL-RISE Trial in the New England Journal of Medicine. The study demonstrated that its FFRangio met non-inferiority to invasive pressure wire guidance in terms of major adverse cardiac events (MACE) at one year, with improved resource utilization and reduced procedure time benefits.

CoMind

Published its first two peer-reviewed papers in Neurophotonics. The companion papers, led by Dominic Hill and Veronika Parfentyeva, demonstrate that its CoMind R1 research prototype achieves the performance required for clinical translation, including high-fidelity pulsatile blood flow measurements and the ability to detect and localize functional brain activity.

CorWave

Appointed Andreas Fleischli as CTO and Daniel Lexcen as VP Clinical & Scientific Affairs as the company prepares for the next stages of scaling its clinical program and industrial set-up. Fleischli brings about 30 years of expertise in the development of Left Ventricular Assist Devices (LVADs), spanning device innovation, engineering, industrialization, regulatory approval, and production scaleup, while Lexcen brings over a decade of experience in heart failure clinical research and global clinical program execution, contributing to the design and execution of numerous international clinical trials across the U.S., Europe, Australia, and Japan.

Echopoint Medical

Secured a $2.5M investment round led by Parkwalk, with participation from UCL Technology Fund, to help advance the company toward its FDA submission and initiate its U.S. clinical program to generate real-world evidence. The company’s iKOr™ platform aims to deliver a true, consistent deep dive into the entire coronary physiology, including critical, often overlooked issues within the microvasculature, all within seconds.

HEPTA Medical

Closed an oversubscribed €10M Series A financing round and welcomed Jérôme Edwards to its Board as an independent member. The round welcomed UI Investissement and Supernova Invest as new investors, alongside existing shareholders Bpifrance, M&L, Cléry, and MD Start, enabling the company to accelerate its clinical execution, strengthen its industrial readiness, and prepare for future regulatory milestones.

HistoSonics

Announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison^Ⓡ Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image-guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies.

Innoventric

Received FDA Breakthrough Device Designation for its Unica™ system, providing the company with an accelerated pathway to bringing the technology to market. The Unica system introduces a heterotopic solution that simplifies tricuspid valve replacement by targeting the caval system rather than the valve itself, sidestepping the complexities of tricuspid valve anatomy and physiology and paving the way for a simple, safe, and effective treatment option.

Lazzaro Medical

Received FDA Breakthrough Device Designation for its LM Scaffold System™. The LM Scaffold System is intended to be used in a robotic-assisted tracheobronchoplasty (R-TBP) procedure to provide structural support to the tracheobronchial airways, reduce dynamic airway collapse, and improve airflow during expiration in patients suffering from tracheobronchomalacia.

Lucida Medical

Secured £8.7M in new funding led by IW Capital with participation from XTX Markets and Macmillan Cancer Support. This investment will accelerate the expansion of the company’s patented AI technology for prostate cancer diagnosis, support product development, and drive international growth and clinical coverage.

MadSci

Announced that Milwaukee Venture Partners (MVP) and Life Science Angels (LSA) have invested in the company. MVP is an angel investment network that provides investment capital, strategic advice, and mentoring to early-stage companies to help them achieve market leadership, and LSA is an angel investing organization whose mission is to improve healthcare worldwide by helping and investing in life science entrepreneurs with disruptive advances in healthcare discovery and delivery.

Prana Surgical

Received FDA clearance for its Prana System™, a single-use electrosurgical tool designed for use with standard generators, enabling physicians to localize and excise tissue in a controlled, minimally invasive manner. Following the clearance, the company plans to initiate a controlled U.S. clinical introduction as part of its broader clinical and commercialization strategy.

Precision Cardiovascular

Welcomed Dr. Morten Hansen as its new VP of Engineering. Hansen brings more than 25 years of experience in implantable medical devices, including senior engineering and program leadership roles at Galvani Bioelectronics and the Alfred Mann Foundation, working across feasibility, product development, surgical development, validation, and regulatory submissions.

PulmoBioMed

Achieved CE Marking for its PBM-Hale™ platform. PBM-Hale enables the collection of breath samples originating from the deep lung while eliminating contamination from the mouth, upper airways, and the environment, delivering highly consistent distal lung samples that plug-and-play with established diagnostic test workflows.

Qaelon Medical

Won the 2026 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Shark Tank Competition and received a $30K first-place cash prize. The company’s proprietary dual-function platform combines leak detection with advanced insufflation, addressing more than 1M procedures annually in the U.S. for leak detection.

Runway Healthcare

Entered into a formal collaboration with Cor Medical Ventures to accelerate the development and commercialization of early-stage medical device innovations, combining complementary capabilities to support companies from concept through exit. The two venture studios will work together to share deal flow and co-invest in promising opportunities across musculoskeletal, cardiovascular, and neurosurgical markets.

Sonavex

Welcomed Curt Scovel as its new VP of Sales, bringing 30 years of experience in the dialysis space, including a long tenure at NxStage Medical, where he served as VP of Sales and Clinical. At NxStage, Scovel led a team of more than 80 professionals, where he played a key role in growing the company from early adopters to hundreds of millions in revenue, resulting in a $2B acquisition by Fresenius.

Sub-Q Bionics

Closed a $1.5M Pre-Seed funding round, including investment from Mayo Clinic, Yeda, and several private investors, with the Israel Innovation Authority also providing matching funds. As part of the round, Mayo Clinic will collaborate with the company on research and development activities for its novel bionic lymph node technology designed to transform how lymphedema is managed.

Superpower

Announced a strategic partnership with GRAIL to bring members access to the Galleri^Ⓡ multi-cancer early detection (MCED) test. The partnership reflects a shared belief that cancer detection must evolve to meet a changing reality, removing traditional barriers to advanced testing and putting earlier insight, data, and control directly in people's hands.

Vicarious Surgical

Completed the initial integrated benchtop testing for its full suite of surgical instruments. This testing, required for the planned first clinical indication of ventral hernia repair for the company’s surgical robot platform, marks a vital step toward design validation, clinical readiness, and the company’s targeted design freeze and first-in-human milestones.

Zeto

Announced FDA 510(k) clearance for Zeto New Wave™, its newest EEG system for outpatient clinics and homes. Zeto New Wave offers a complete, easy-to-use outpatient routine EEG solution, featuring a full head coverage with 21 soft-tip, no mess electrodes placed according to the widely used 10–20 system.

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.