May 16, 2025

The Weekly Recap 5/16/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

The Weekly Recap 5/16/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

Weekly Recap 16_9 - 05.16.2025

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, announce commercialization, raise new funds, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).

Adtec Healthcare

Received European MDR certification for its SteriPlas cold plasma technology, marking a major regulatory milestone. SteriPlas is a microwave-driven argon plasma device designed to treat chronic and hard-to-heal wounds by reducing bacterial load and promoting healing.

Axoft

Announced the commercialization of Fleuron™, a groundbreaking soft material for implantable brain-computer interfaces (iBCIs), now available for R&D use. Mimicking the mechanical properties of brain tissue, Fleuron is up to 10,000x softer than traditional implant materials and designed to reduce scarring, prevent lead migration, and improve long-term signal stability.

BrightHeart

Secured FDA 510(k) clearance for B-Right Views, an AI-powered tool that confirms complete fetal heart documentation during anatomy scans, alongside approval of its Predetermined Change Control Plan (PCCP). With this dual milestone, BrightHeart becomes the first to offer an integrated solution that detects required cardiac views and flags congenital heart defect markers in real time, while enabling pre-authorized AI updates to continuously enhance clinical value.

Elucent Medical

Received FDA Breakthrough Device Designation for its EnVisio X1™ In-Body Spatial Intelligence™ System, a next-generation surgical guidance platform designed to elevate precision in soft tissue cancer surgeries. The system enables real-time, non-image detection, localization, and surgical navigation of the SmartClip® and tracked surgical instruments, potentially reducing positive margins and re-excisions in minimally invasive thoracic and abdominal procedures.

Freespira

Received FDA clearance to expand its at-home, drug-free anxiety disorder treatment to adolescents ages 13–17. The 28-day, capnometry-guided respiratory intervention system demonstrated a 54% mean reduction in panic disorder symptom severity on the Panic Disorder Severity Scale for Adolescents (PDSS-A) and a 44% mean reduction in PTSD symptoms on the PTSD Checklist (PCL-5).

Hy2Care

Raised €4.5M to prepare for its U.S. clinical trial and global expansion plans for CartRevive®, a minimally invasive hydrogel implant for cartilage repair. Backed by the European Innovation Council Fund and strategic investors including Brightlands Venture Partners, the funding will accelerate preparations following FDA IDE approval and lay the groundwork for commercial rollout in Europe and beyond.

Insight Surgery

Secured $2.5M in Series A funding to scale its FDA-cleared, patient-specific surgical guide platform across the United States. Backed by Nodenza Venture Partners, the company will expand manufacturing, grow its U.S. team, and explore AI integrations to enhance surgical outcomes in orthopaedics and beyond.

Lionheart Health

Was selected to advance as an XPRIZE Healthspan Top 40 Milestones 1 awardee. The company’s inclusion in the first round of winners highlights its leadership in developing proactive therapeutics aimed at helping people live longer, healthier lives.

OncoHost

Secured a €2.5M Horizon Europe grant together with its partners—Heidelberg University Hospital, European Institute of Oncology, and Virgen Macarena University Hospital—to advance precision oncology for patients receiving immunotherapy. OncoHost is developing a novel biomarker to predict response to immune therapy across five indications.

Oath Surgical

Emerged from stealth this week with the launch of OathOS, a vertically integrated platform that connects patients, providers, and payors through a unified, tech-enabled surgical experience. Backed by Oxford Science Enterprises and led by CEO Dr. Oliver Keown, Oath is reimagining outpatient surgery through digital-first centers and a surgeon-led model purpose-built for value-based care. Stay tuned for Oath’s exclusive feature in The Memo this Sunday.

Onera Health

Was awarded the MedTech Breakthrough Awards 2025 in the category of “Medical Device – Best New Technology Solution – Diagnostic.” The MedTech Breakthrough Awards spotlight top-performing companies that are redefining the future of medical technology, and Onera is proud to be among this year’s standout innovators.

Prevencio

Received FDA Breakthrough Device Designation for HART CADhs®, the only AI-driven multi-protein blood test designed to detect obstructive coronary artery disease through a simple blood draw. The designation supports the company’s goal of transforming HART CADhs into a rapid, FDA-cleared diagnostic tool for emergency care settings.

Synchron

Announced it will be the first brain-computer interface (BCI) company to natively integrate with Apple’s newly introduced BCI Human Interface Device (BCI HID) profile, enabling individuals with motor impairments to control iPhones, iPads, and Apple Vision Pro using only their thoughts. This major accessibility milestone, powered by Synchron’s Stentrode™ implant and AI-driven system, represents a new input category.

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.