MedTech Startup Roundup – Vol.2 No.7

Dan’s Picks

Median Technologies: AI, Soft/SaaS, Diagnostic, Oncology – Sophia-Antipolis, France

Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening

Product Launches

IntelePeer: AI, Soft/SaaS, Conversational AI, Collections, Dental, Medical – Dania Beach, FL

IntelePeer Introduces SmartAgent Collections, Automated Revenue Recovery Solution for DSOs and Specialty Healthcare Providers

BillionToOne: Diagnostic, Liquid Biopsy, Oncology, Obstetric – Menlo Park. CA

BillionToOne Announces Dual Launch of UNITY Expanded Red Blood Cell and Platelet Fetal Antigen NIPTs, Extending Its Leadership In Setting the New Standard in Prenatal Care

Sky Labs: RPM, Blood Pressure – Seoul, South Korea

Sky Labs Launches ‘CART ON’, the World’s First Ring-Type Wearable Blood Pressure Monitoring Solution for Hospital Wards

Oxipit: AI, Soft/SaaS, Imaging Interpretation – Vilnius, Lithuania

Oxipit expands radiology AI portfolio beyond CXR with CT Eye™ and MSK Eye™

WoundZoom: Imaging, Diagnostic, Wound Care – Boca Raton, FL

WoundZoom Launches WoundBot and Single Sign-On to Enhance Decision-Making and Clinical Efficiency

M&A

Acquisition
TheraB Medical : Wearable Phototherapy, Neonatal – East Lansing, MI
Natus Sensory: Sensory Care, Neonatal – Schaumburg, IL

Natus Sensory Acquires TheraB Medical to Expand Innovation in Neonatal Phototherapy

IPOs

BioVentrix: Implant, Less Invasive, Heart Failure, Cardiothoracic Surgery – Mansfield, MA

Cardiac medical device developer BioVentrix files for an $17 million IPO

The Cs

Ambience Healthcare: AI, Ambient, Soft/SaaS, Clinical Documentation – San Francisco, CA

Mike Valli – CRO – Revenue (Joining)

Ambience Healthcare Appoints Mike Valli as Chief Revenue Officer and Chief Value Officer

IceCure Medical: Procedural Device, Minimally Invasive, Cryoablation, Breast Cancer – Caesarea, Israel

Ronen Tsimerman – CFO (Resigning)

IceCure Announces Planned Departure of CFO Following Nine Years of Service and Key Milestones Achieved

Viz.ai: AI, Soft/SaaS, Diagnostic, Oncology – San Francisco, CA

Jallel Harrati – CRO – Revenue (Joining)

Viz.ai Appoints Jallel Harrati as Chief Revenue Officer to Accelerate Enterprise Growth

HiLabs: AI, Soft/SaaS, Clinical Data – Bethesda, MD

Chris Gengo – CIO – Innovation (Joining)

Chris Gengo Joins HiLabs as Senior Vice President and Chief Innovation Officer

Nabla: AI, AI Assistant – Paris, France

Matt Sakumoto, MD – CCPO – Clinical Product (Joining)

Nabla Deepens Clinical Leadership with Appointment of Dr. Matt Sakumoto as Chief Clinical Product Officer

Episurf Medical: Implant, Orthopedic Surgery – Stockholm, Sweden

Jens Andersson – CEO (Joining)
Katarina Flodström – CEO – Deputy (Demotion)
Sanja Batljan – CFO (Joining)
Pål Ryfors – CFO (Departing)

Episurf Medical announces leadership changes effective from 11 February 2026

Hippocratic AI: AI, Generative AI Agents – Palo Alto, CA

Niloy Sanyal – CMO – Marketing (Joining)

Hippocratic AI Announces New Key Executive Appointments to Further Accelerate Growth

Vitalacy: AI, Soft/SaaS, Pt. Safety, Remote Monitoring – Los Angeles, CA

Haley Dukelow – CEO (Promotion)

Vitalacy, Inc. Appoints Haley Dukelow as Chief Executive Officer

Innovative Sterilization Technologies: Sterilization System – Dayon, OH

Tim Tzimas – CEO (Joining)

Tim Tzimas Named President and CEO of Innovative Sterilization Technologies/ONE TRAY

Board Members

TriSalus Life Sciences: Procedural Device, Drug Delivery, Interventional Oncology – Westminster, CO

Michael Stansky – Board Member (Joining)

TriSalus Life Sciences Appoints Veteran Healthcare Investor Michael Stansky to its Board of Directors

Episurf Medical: Implant, Orthopedic Surgery – Stockholm, Sweden

Jens Andersson – Board Member (Joining)

Episurf Medical announces leadership changes effective from 11 February 2026

Funding

Exact Imaging: Imaging, Ultrasound, Prostate, Urology – Markham, ON

iGan Partners Leads $10 Million Financing of Exact Imaging, the World’s Leading Prostate Cancer Detection Platform

Neurent Medical : Procedural Device, ENT – Galway, Ireland

Neurent Medical Raises €62.5 million in Oversubscribed Series C Financing to Accelerate NEUROMARK® Commercial Expansion to treat Chronic Rhinitis

OSSIO: Implant, Bio-Integrative, Orthopedic Surgery, Suture Anchor – Woburn, MA

Horizon Technology Finance and Monroe Capital Support OSSIO with a $50 Million Credit Facility for Continued Growth

Entirety Biomedical: Implant, Absorbable Fixation, Orthopedic Surgery – East Lansing, MI

Entirety Biomedical Closes $1.2 Million Seed Financing to Advance Absorbable Magnesium Implants for Orthopedic Fixation

Big Health: Digital Medicine, Mental Health – San Francisco, CA

Big Health Secures Funding to Accelerate Adoption of Digital Mental Health Treatments

OncoRes Medical : Imaging, Surgical, Oncology – Perth, Australia

Australian Breast Cancer Innovators Close $27M Private Funding Round

Berlin Heals: Implant, Electroceutical, Cardiology, Heart Failure – Berlin, Germany

Berlin Heals Successfully Raises Over 10M USD to Expand the New Less Invasive Approach to More Heart Failure Patients

Helia Care: Soft/SaaS, Hospital Procurement – Scottsdale, AZ

Helia Care Ramps Growth, Sets Sights on $10 Billion Savings Milestone with Support from In Revenue Capital and Habanero Ventures

Catheter Precision: Procedural Device, E-P – Fort Mill, SC

Catheter Precision, Inc. Secures up to $36.5 Million in Strategic Institutional Financing to Accelerate Growth

Regulatory

Approval
UV Smart: Capital Equip, UV Disinfection – Rijswijk, The Netherlands

UV Smart Announces FDA 510(k) Clearance for D60 TEE Probe Disinfection System

Approval
Median Technologies: AI, Soft/SaaS, Diagnostic, Oncology – Sophia-Antipolis, France

Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening

Submittal
Peijia Medical: Procedural Device, Interventional, Structural Heart, Neurovascular – Suzhou, China

Peijia Medical Submits EU MDR CE Mark Registration Application for GeminiOne® TEER System

Approval
Vesalio: Procedural Device, Thrombectomy Catheter, Peripheral Vascular, Neurovascular – Plano, TX

Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters

Approval
Encora Therapeutics: Wearable, Essential Tremor, Neurology – Boston, MA

Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1™, a Breakthrough Wearable Device for Essential Tremor

Approval
StimLabs: Biologic, Wound Care – Roswell, GA

StimLabs® Announces FDA 510(k) Clearance for DermaForm™, a Collagen Scaffold Particulate Wound Care Device

Approval
Amferia: Disposable, Infection Control – Mölndal, Sweden

FDA Grants De Novo Classification Request to Market the World’s First Antibacterial Peptide-Based Wound Dressing

Approval
InVera Medical: Device, Infusion Catheter, Minimally Invasive – Galway, Ireland

InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device

Approval
EYE PCR: Procedural Device, IOL Implantation Assist, Ophthalmic Surgery – Amsterdam, The Netherlands

EYE PCR Receives CE Mark for fixOflex Endocapsular Device, Enabling European Market Introduction

Product News

restor3d: 3D Printing, Implants, Orthopedic – Durham, NC

restor3d Announces Full Commercial Launch of Ossera™ AFX Ankle Fusion Cage System, Immediately Available in Both Standard and Made-to-Order Options

Carlsmed: AI, Implant, Spine – Carlsbad, CA

Carlsmed Announces First aprevo® Bi-lateral Posterior Lumbar Interbody Fusion Procedure

Zavation Medical: Implant, Spine Surgery – Flowood, MS

Zavation Medical Products Unveils Next-Generation Cervical Interbody Featuring the Combined Power of NanoPrime® and Labyrinth® Porous PEEK

Ambience Healthcare: AI, Ambient, Soft/SaaS, Clinical Documentation – San Francisco, CA

Ambience Healthcare Expands “Chart Awareness” Across Its Intelligence Platform

Reimbursement

Personalis: Diagnostic, Liquid Biopsy, Genomics, Oncology – Fremont, CA

Personalis Receives Medicare Coverage for NeXT Personal® in Lung Cancer Surveillance

Clinical Trials/Studies

Atraverse Medical: Procedural Device, Cardiac Surgery – Cardiff by the Sea, CA

New Data Presented at AF Symposium Show Atraverse Medical’s HOTWIRE™ System Mitigates Unintended Left Atrial Injury With Reduced RF Delivery

Cala Health: Wearable, Neuromodulation, Essential Tremor, Parkinson’s Disease, Neurology, – San Mateo, CA

Published Study Found Underlying Tremor Improvement with Consistent use of Cala TAPS Therapy in Patients with Essential Tremor

Argá Medtech: Procedural Device, PFA, Cardiac Ablation – Epalinges, Switzerland

Argá Medtech Reports 94% Lesion Durability and Strong Safety Profile in First-in-Human BURST-AF Trial of Single-Catheter PFA System

Ferronova: Diagnostic, Cancer Cell Identification, Image-Guided Surgery – Adelaide, Australia

Medical biotech Ferronova completes enrolment for gastric and oesophageal cancer image-guided surgery trial.

AccurKardia: Soft/SaaS, ECG Interpretation – New York, NY

Study Shows AccurKardia’s AI-Enabled ECG Can Detect Aortic Stenosis Years Before Valve Replacement and Improve Mortality Risk Prediction

Canary Speech: AI, Soft/SaaS, Clinical Decision Support, Voice Biomarkers – Provo, UT

Canary Speech and Intermountain Ventures Launch Groundbreaking Study to Identify Multiple Sclerosis Using Vocal Biomarkers

Valar Labs: AI, Diagnostic, Predictive Medicine, Urology, Bladder Cancer – Palo Alto, CA

Valar Labs Publishes Pivotal Study in Journal of Clinical Oncology Validating AI to Predict Chemotherapy Response for Pancreatic Cancer Patients

Corvia Medical: Implant, Interventional Cardiology – Tewksbury, MA

New Hope for “Huff-Puff” Heart Failure Patients: Long Beach Medical Center Helps Lead Global Trial of First HFpEF Device

Valcare Medical: Implant, Procedural Device, THV, Interventional Cardiology – Herzlyia Pituach, Israel

Valcare Medical Announces First U.S. Transseptal AMEND™ Implant in Early Feasibility Study

Onkos Surgical: Implant, Orthopedic, Antibacterial Coating – Parsippany, NJ

Onkos Surgical® Announces Initiation of 522 Post-Market Surveillance Study of the ELEOS™ Limb Salvage System with NanoCept® Antibacterial Implant Technology

Immunexpress : Diagnostic, Rapid, Sepsis, Infectious Disease – Seattle, WA

Immunexpress Announces Publication Showing SeptiCyte RAPID® Identifies Septic Patients Most Likely to Have Positive Blood Cultures

AutoIVF: Capital Equip, In Vitro Fertilization (IVF) – Watertown, MA

AutoIVF Publishes Peer-Reviewed Nature Medicine Study Evaluating Oocyte Recovery Variability in IVF Using an Automated Microfluidic System

Kandu, Inc.: Rehabilitation, Post-Stroke, Neurology – Van Nuys, CA

Randomized Controlled Trial Demonstrated Positive Outcomes for FDA-Cleared Brain-Computer Interface IpsiHand® System in Chronic Stroke Rehabilitation

VIVEX Biologics: Allograft, Spine, Orthopedic, Wound, Burn – Miami, FL

Vivex Announces New Peer-Reviewed Publication Demonstrating Long-Term Fusion Outcomes with VIA Form+™ in Lumbar Interbody Fusion

Patents

Second Heart Assist: Ventricular Assist Device, Cardiology – Salt Lake City, UT

Second Heart Assist Granted U.S. Patent for Core Circulatory Support Platform