The Weekly Recap 12/12/25: 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 receive regulatory approvals, secure new funding, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

AQUAPASS 

Received marketing approval in Israel for the AQUAPASS System, enabling initial commercial rollout of its non-invasive, kidney-independent fluid removal therapy. The milestone marks the company’s transition into a commercial phase as it advances the REFORM-HF pivotal trial toward FDA submission in early 2026.

Bendit Technologies

Received FDA 510(k) clearance for the Bendit17™ Microcatheter, the smallest steerable microcatheter on the market. The clearance paves the way for initiation of the first U.S. commercial clinical procedures beginning in early 2026, while the company pursues additional regulatory clearances in other global markets in parallel.

Berlin Heals

Appointed Rob ten Hoedt as the new Chairman of its Board of Directors, bringing more than 30 years of global leadership in medtech and healthcare to guide the company’s next phase of growth. His experience and strategic vision will support Berlin Heals as it advances its C-MIC cardiac microcurrent therapy into a pivotal year.

Cardiawave

Received CE mark approval for Valvosoft^Ⓡ, the first non-invasive therapeutic alternative for treating severe symptomatic aortic stenosis. The approval follows strong feasibility, safety, and efficacy data, enabling European availability of the company’s ultrasound-based therapy.

FeelTect

Secured €6.3M in DTIF funding for the HealAsystant consortium to advance an AI-assisted, end-to-end self-management system for compression therapy. The project will build on the company’s Tight Alright platform with individualized treatment plans, closed-loop compression, enhanced patient engagement, and AI-powered decision support.

HeartBeam

Received FDA 510(k) clearance for its first-of-its-kind, cable-free, synthesized 12-lead ECG, enabling at-home arrhythmia assessment. The clearance supports a limited U.S. launch in early 2026 and advances the company’s roadmap toward wearable integration and a future heart attack detection indication.

INBRAIN Neuroelectronics

Appointed Scott Huennekens as Chairman of its Board of Directors to help guide the company’s graphene-based brain-computer interface therapeutics into pivotal trials and commercialization. He brings more than two decades of experience founding, scaling, and advising breakthrough healthcare technology companies.

Joint Preservation Innovations

Received FDA 510(k) clearance for the Articulator™ Arthroscopic Bur, the first and only FDA-cleared articulating rotary cutting instrument designed for use in arthroscopic procedures. According to the company, its patented articulating mechanism provides up to 601% greater cutting surface area compared to traditional straight burs.

Kitea Health

Closed a $13M investment round as the company continues to advance its implantable device for continuous monitoring of brain pressure in patients with hydrocephalus. Additional details will be shared in 2026, following a year marked by a new facility, team growth, first clinical data, and encouraging surgeon feedback.

Lungpacer Medical

Reported the first commercial procedures using its FDA-cleared AeroPace^Ⓡ diaphragm neurostimulation system. The first commercially treated patient, unable to wean from mechanical ventilation for three weeks, progressed from full mechanical ventilation support to breathing independently with a trach collar after 12 days of AeroPace therapy and was discharged two days later.

Medical Microinstruments

Received FDA 510(k) clearance for its NanoWrist^Ⓡ Scissors and Forceps and recently completed the first U.S. clinical use at Tampa General Hospital. According to MMI, the lymphovenous bypass procedure, leveraging the full capabilities of Symani^Ⓡ, is the world’s first fully robotic-assisted microsurgical operation from initial incision to skin closure.

Mirai Medical

Was awarded €7.2M through DTIF to advance PIONEER, a national program developing a new, minimally invasive treatment for colorectal cancer. PIONEER will advance the clinical development of Mirai Medical’s ePORE^Ⓡ platform, a non-thermal, PFA solution designed to preserve healthy tissue and reduce the need for radical surgery.

Nephrodite

Reported the first successful multi-day large animal study of Holly™, its fully implantable renal replacement device, demonstrating continuous kidney function replacement over 72 hours. The breakthrough supports progress toward GLP studies and first-in-human trials for a potential alternative to traditional dialysis.

Nitinotes Surgical

Announced the first patient treated in its pivotal EASE IDE trial evaluating the EndoZip™ automated suturing system for endoscopic sleeve gastroplasty (ESG). The study compares automated ESG to the manual OverStitch™ technique and is designed to support future U.S. regulatory submission, building on EndoZip’s recent CE Mark approval.

Perimeter Medical Imaging AI

Announced the successful closing of a private placement, raising gross proceeds of C$3.6M. The financing will accelerate commercialization of the S-Series OCT device and advance product development for the AI-enabled B-Series device, which remains under FDA review with a decision expected in the first half of 2026.

Pulse Biosciences

Announced a research collaboration with MD Anderson Cancer Center to evaluate its nPulse™ Vybrance™ system for thyroid cancer, supported by an FDA-approved IDE for a first-in-human study. The study, beginning in 2026, will assess nanosecond PFA in papillary thyroid microcarcinoma.

Scout Health

Was awarded up to $6M in additional CARB-X funding to finalize development of STI Scout, the company’s low-cost rapid molecular diagnostic for gonorrhea and chlamydia. The investment also supports early deployment planning in low- and middle-income settings, advancing Scout’s mission to expand global access to accurate molecular STI testing.

Vektor Medical

Received FDA 510(k) clearance for its next-generation vMap technology. The clearance expands vMap’s non-invasive mapping capabilities with several enhancements, including atrial flutter mapping, direct ECG and data streaming, 3D model import and visualization, SaMD deployment, and secure local and remote connectivity.

restor3d

Completed the first clinical cases using the iTotal Identity™ CR 3DP Porous Fully Personalized Total Knee Replacement System. The milestone follows FDA clearance earlier this year and advances restor3d’s fully personalized, cementless knee arthroplasty solution toward a full commercial launch.

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.