The Weekly Recap 1/30/26: 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 secure new funding, receive regulatory clearances, launch products, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

Amplifi Vascular

Was granted FDA Breakthrough Device Designation and Category B assignment from the CMS for its Amplifi™ Vein Dilation System, supporting accelerated development of a technology designed to enhance vein size and quality prior to AV fistula creation for hemodialysis access. The milestone was backed by first-in-human data from 19 patients and strengthens Amplifi’s path toward broader regulatory engagement and future patient access.

Augmedit

Announced that clinical teams at Amsterdam UMC and UMC Utrecht Brain Center successfully completed the first use of LumiNE Elite for external ventricular drain placement. LumiNE Elite provides patient-specific three-dimensional visualization by converting standard 2D imaging into interactive 3D holograms using augmented reality and is designed to support surgeons during procedures that rely on accurate spatial orientation. 

Axena Health

Expanded its collaboration with Mayo Clinic to improve treatment options for women with pelvic floor disorders. The expanded collaboration will involve developing a new AI-powered solution (separate from Leva^Ⓡ) to help women with bladder leakage and their doctors stay engaged in treatment and offer personalized care based on each woman’s unique symptoms and response to treatment.

HighLife

Received CE Mark approval for the HighLife Transcatheter Mitral Valve Replacement (TMVR) System for the treatment of adult patients suffering from symptomatic moderate-severe or severe mitral valve regurgitation (MR), who are deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair. The milestone supports a phased European rollout of the system, backed by clinical experience demonstrating sustained MR reduction and meaningful improvements in patient function and quality of life.

Invenio Imaging

Appointed Adrian Whitford as an Independent Board Director, bringing deep global commercialization and marketing leadership across oncology and digital health. The company also welcomed Biao He of Oak BioCapital and John Seamans of Michigan Biomedical Venture Fund to its Board of Directors, strengthening leadership as Invenio advances commercialization.

iSono Health

Launched ATUSA, the world’s first FDA-cleared, wearable, and automated 3D breast ultrasound platform, enabling rapid, operator-independent breast imaging at the point of care. The commercial rollout coincides with the initiation of the NIH-supported AUDIBLE multicenter clinical trial, which will compare the diagnostic performance of ATUSA with that of traditional mammography and MRI.

Nalu Medical

Announced that its acquisition by Boston Scientific has been completed, expanding Boston Scientific’s chronic pain portfolio with Nalu’s neurostimulation platform for spinal cord and peripheral nerve stimulation. The transaction strengthens Boston Scientific’s ability to deliver a broader suite of evidence-based therapies for pain management.

Nami Surgical

Appointed Nikki Palfrey as CEO and completed a £1.9 million investment round to support its transition toward commercialization of its miniaturized ultrasonic surgical platform for robotic-assisted surgery. The funding and leadership expansion strengthen Nami’s strategy as it advances ultrasonic scalpels engineered for integration into next-generation robotic systems.

Noor Sciences

Was granted its first U.S. patent protecting its novel approach to embryo viability assessment. Noor Sciences is advancing a new standard for embryo assessment in IVF through a fully non-invasive, AI-driven platform designed to deliver objective, actionable insight at the most critical decision points in the fertility journey.

Oath Surgical

Announced a collaboration with NVIDIA to support the OathOS platform, a multimodal, ambient clinical intelligence system designed to orchestrate the next generation of value-based surgery. The collaboration will bring NVIDIA’s advanced spatial AI infrastructure to Oath Surgical’s AI-native surgical centers, powering OathOS with real-time surgical video and audio analysis and agentic workflows in the operating room, and delivering unique insights and efficiencies for surgeons across the full care journey from referral to recovery. 

ReGelTec

Appointed Seth A. Kaufman as Vice President of Clinical Affairs, strengthening the company’s leadership as it advances the HYDRAFIL^Ⓡ System. ReGelTec’s HYDRAFIL System is a minimally invasive, percutaneous hydrogel implant designed to treat chronic low back pain caused by degenerative disc disease.

Robocath

Announced the launch of a first-in-human clinical study evaluating its second-generation robotic system in coronary artery disease. The 20-patient study, taking place at Centre Cardiologique du Nord in France, will assess complex cases representative of the routine activity of a catheterization laboratory.

SamanTree Medical

Secured €20M in financing from the European Investment Bank (EIB), with the support of the InvestEU programme. The financing will support the continued development and commercialization of the Histolog^Ⓡ Scanner in Europe and the United States.

Skybound Medtech

Was officially launched by LSI Alumni Matthew Kuhn, backed by $5M in early committed capital toward a $25 million raise. Skybound Medtech is developing a portfolio of transformative dual-use medical technologies at the intersection of space medicine, longevity medicine, and national defense.

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.