The Weekly Recap 10/24/25: 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 new funding, announce regulatory clearances, achieve clinical milestones, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

Access Vascular

Announced that the FDA cleared a new indication for its single-lumen MIMIX^Ⓡ HydroMid^Ⓡ and single- and dual-lumen HydroPICC^Ⓡ catheter lines. With this updated labeling, the MIMIX HydroCatheters are the only FDA-cleared, drug-free peripherally inserted central catheters (PICCs) and midline catheters (MIDs) indicated as anti-thrombogenic. 

Adaptyx Biosciences

Raised $14M in seed funding to support development of its biowearable patch for multi-analyte molecular monitoring. The company plans to use the proceeds to accelerate R&D and product development, expand its molecular switch pipeline, support ongoing clinical trials, and scale its team across engineering, data science, and clinical operations.

Berlin Heals

Appointed Dr. Eric Fain to its Board of Directors to support the next phase of development of its C-MIC for heart failure. Dr. Fain brings over 35 years of strategic and startup expertise, with extensive experience in the cardiovascular space, bolstering the company’s strategy ahead of U.S. clinical studies and eventual FDA submission.

CoMind

Secured $102.5M in funding to advance CoMind One, a non-invasive brain monitoring platform designed to provide real-time insights on cerebral perfusion, autoregulation, and intracranial pressure. The company plans to use the funds to support regulatory efforts, clinical trials, team expansion, and manufacturing partnerships.

DASI Simulations

Announced a strategic partnership with Medtronic to integrate DASI’s FDA-cleared AI-based predictive modeling and digital twin technology into the TAVR workflow. The collaboration aims to support personalized valve treatment planning, optimize patient outcomes, and scale simulation-based care across structural heart programs nationwide.

GT Medical Technologies

Reported interim results from its Phase 3 ROADS trial showing that GammaTile^Ⓡ reduced the risk of tumor recurrence or death by more than 50% compared to standard of care. The implantable radiation therapy, which delivers immediate, targeted treatment at the time of brain tumor removal, demonstrated superior efficacy without increasing treatment-related side effects.

InkSpace Imaging

Received FDA 510(k) clearance for its flexible MR coil for Philips 3.0T systems, expanding access to its next-generation coil technology. With this milestone, InkSpace’s flexible coil technology is now available across all three major MRI OEMs (Siemens Healthineers, GE HealthCare, and Philips).

Mesh Suture

Received MDR and MDSAP certifications for its DURAMESH™ technology, ensuring regulatory compliance across the EU, the U.S., Canada, Brazil, and Australia. The approvals support Mesh Suture’s global expansion plans and affirm its commitment to delivering safe and effective surgical closure solutions globally.

Microsure

Appointed Monika E. Hagen as its new Chief Medical Officer to lead clinical development of the company’s MUSA microsurgical robotics platform. In this role, she will drive roadmaps and trials, regulatory alignment, KOL partnerships, surgeon education, and cross-functional execution.

Noah Medical

Shared positive results from two studies evaluating its Galaxy robotic bronchoscopy platform, presented at CHEST 2025. According to the company, the findings validate Galaxy’s embedded imaging technology, demonstrating consistent diagnostic performance and efficiency.

Nyra Medical

Initiated its first-in-human study evaluating its novel cardiac leaflet enhancer (CARLEN) system in patients with functional mitral regurgitation. CARLEN is a single-leaflet implant that is intended to restore coaptation while preserving the valve’s natural motion and orifice area.

Petal Surgical

Emerged from stealth with nearly $20M in funding, including a $10M Series A co-led by K50 Ventures and TSVC. The company is developing an incisionless surgery approach that combines acoustic liquefaction, AI, and robotics to eliminate cutting, pain, trauma, and other surgical risks.

Prevencio

Expanded its global IP portfolio with new patents in the UK and Hong Kong for its AI-powered HART CADhs^Ⓡ blood test for diagnosing obstructive coronary artery disease. The company now holds six U.S. and international patents, strengthening its leadership in cardiovascular diagnostics.

Raydiant Oximetry

Announced the successful completion of a 35-patient Early Feasibility Study of its fetal pulse oximetry platform at Eastern Virginia Medical School. The data will support the development of machine learning algorithms to enhance labor and delivery outcomes for mothers and babies.

SpectraWAVE

Received FDA 510(k) clearance for X1™-FFR, an AI-enabled, wire-free, drug-free physiology tool that delivers FFR results from a single angiogram in under a minute. Offered as an add-on to the company’s HyperVue™ Imaging System, X1-FFR enables the first and only platform in the U.S. that combines FDA-cleared angiogram-derived physiology with intravascular imaging.

VitVio

Closed an $8M seed round to accelerate deployment of its surgical AI platform designed to make operating rooms more efficient with less administrative burden. The funding will support continued expansion into major U.S. hospitals.

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.