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.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-13026-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

Comments

Post a Comment

Popular posts from this blog

Cover Story: A Page from Ray Cohen’s Playbook: Scaling, Exiting, and Winning in Medtech

With four decades of company-building, IPOs, boardroom leadership, and monumental exits behind him, Raymond W. Cohen has become one of medtech’s most successful operators. But behind the financial wins — including the recent back-to-back $3.7 billion Axonics and $600 million SoniVie acquisitions by Boston Scientific — is a deeper story of Cohen’s contrarian, full-transparency, people-centered, no-BS approach to leadership and strategy. “People crave inspired, authentic, and transparent leadership that thinks big and acts boldly. They want to be enrolled in a vision of what is possible, and be recognized and compensated for creating measurable results, not be fed a bunch of platitudes.” A quote that is classic  Ray Cohen  — blunt, unapologetic, no-nonsense, and grounded in hard-won experience. With more than four decades in medtech, Cohen has done what many aspire to — build, lead, scale, and sell high-stakes, successful ventures with precision and zero fluff. Known for his no-...
Read more

The Weekly Recap 6/13/25: 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 $63M in new funds, receive FDA 510(k) clearances, announce an acquisition, and much more as we wind down   LSI Asia  ’25 in Singapore and gear up for  LSI Europe  ’25 in London (September 7–11). Accelus Received FDA 510(k) clearance for the FlareHawk Interbody Fusion System to be safely subjected to MRI scanning in certain conditions. The clearance supports Accelus’s commitment to safe, high-performance spinal solutions and expands imaging options for patients with FlareHawk implants. Aortyx Raised $16M to advance its bioresorbable aortic patch toward first-in-human trials. The funding supports continued development of Aortyx’s minimally invasive, tissue-regenerating solution for aortic dissection and positions the company for clinical entry within two years. Atraverse Medical Closed $29.4M in follow-on financing to scale U.S. commercialization of HOTW...
Read more

Medtech in 2025: Key Insights from Q1 Earnings

  As we venture into Q2 of 2025, the medtech industry continues to navigate challenges while remaining on a positive growth trajectory. The early earnings reports from major medtech companies provide valuable insights into how the sector is performing and where it is heading. Despite the pressures of ongoing macroeconomic uncertainty, the first quarter of 2025 shows a sector that’s resilient, with many companies reporting strong growth across their key divisions. For more information visit here:  https://www.slideshare.net/slideshow/medtech-in-2025-key-insights-from-q1-earnings/279045324
Read more