MedTech Startup Roundup – Vol.1 No.23

The news you need on MedTech startups

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CustoMED: 3D Printing, Implants, Orthopedic – Ramat Gan, Israel

CustoMED Announces $6M Funding to Scale AI-Powered 3D Printed Solutions for Orthopedic Surgery

Product Launches

Icarus Medical: DME, High-Tech Orthotics – Charlottesville, VA

Icarus Medical Launches the Sidewinder Dial System for Prosthetic Fabrication and Design

Altera Digital Health: Soft/SaaS, EHR, Data Platform – Niagara Falls, NY

Altera Digital Health Launches CareInTelligence, a Data Platform for Payers, Providers and Community Outreach

Elucid: AI, Imaging, Diagnostic, Cardiovascular, Atherosclerosis Risk Assessment – Boston, MA

Elucid Launches PlaqueIQ Image Analysis Software for the Carotid Arteries

VideaHealth: AI, Dental, Orthodontic, Aligner & Implant Case ID – Boston, MA

VideaHealth Launches Voice Notes, the First Ambient AI Scribe Purpose-Built for Dentistry

M&A

Sunwave Health: AI, Soft/Saas, Practice Mgt, Behavioral Health – Delray Beach, FL
Lightning Step Technologies: AI, Soft/Saas, Practice Mgt, Behavioral Health – Houston, TX

Sunwave Health and Lightning Step Merge and Secure Strategic Growth Investment from BVP Forge

Acquisition
Stone Clinical Laboratories: Diagnostic, Service, Clinical Lab – New Orleans, LA
Fibronostics: Diagnostic, Liver, Metabolic – Orlando, FL

Fibronostics Acquires Stone Clinical Laboratories to Advance MASH/MASLD Diagnostics

The Cs

Sightview Software: Soft/SaaS, EHR, Practice Mgt, Ophthalmology – Durham, NC

Scott Foster – CFO (Joining)

Scott Foster, CPA, MBA, Joins Sightview as Chief Financial Officer

Board Members

PainTEQ: Implant, Allograft, Spine Surgery – Tampa, FL

Robert Kline – Board Member (Joining)

PainTEQ Scales Leadership: Med-Tech Catalyst Robert Kline Joins Board to Drive New Standard in Interventional Spine Care

Episurf Medical: Implant, Orthopedic Surgery – Stockholm, Sweden

Laura Shunk – Board Member (Resigning)

Board Member Resigns from the Board of Episurf Medical

Funding

Co-Diagnostics : Diagnostic, Molecular – Salt Lake City, UT

Co-Diagnostics, Inc. Announces Pricing of $7.0 Million Registered Direct Offering of Common Stock Priced At-The-Market Under Nasdaq Rules

Curve Biosciences: Precision Medicine, Diagnostic, Chronic Disease – San Mateo, CA

Curve Biosciences Raises $40 Million to Bring Whole-Body Intelligence to Chronic Disease Monitoring

CustoMED: 3D Printing, Implants, Orthopedic – Ramat Gan, Israel

CustoMED Announces $6M Funding to Scale AI-Powered 3D Printed Solutions for Orthopedic Surgery

Sparrow BioAcoustics: AI, Diagnostic, Cardiology – St. John’s, NL

Sparrow BioAcoustics Secures $10 Million to Support Expanding U.S. Deployment of Smartphone-Based Cardiac A

Surgical Automations: AI, Robotic, Surgical, GI Endoscopy – Dallas, TX

Surgical Automations Announces Closing of $3.4 Million Oversubscribed Seed Round

Archy: AI, Soft/SaaS, Practice Mgt, Dental – San Jose, CA

Archy Raises $20M Series B to Put Dental Practices on Autopilot

Regulatory

Approval
Bot Image: AI, Soft/SaaS, Imaging, Cancer, Oncology, Urology – Omaha, NE

Bot Image, Inc. Earns CE Mark Certification for ProstatID® AI Prostate MRI Software Under EU MDR

Approval
Perimetrics: AI, Capital Equip, Diagnostic, Dental – Redmond, WA

FDA Grants Clearance for the First-Ever Technology to Measure “Internal” Mobility in Teeth — Generally Associated with Cracks and Loose Restorations

Approval
Lumendi: Procedural Devices, Endoscopic, GI – Zug, Switzerland

LUMENDI RECEIVES CE MARK FOR DILUMEN™ EZ¹ AND DILUMEN™ C¹, EXPANDING FOOTPRINT IN THE EUROPEAN MARKET

Approval
Sirona Medical: AI, Soft/SaaS, PACS, Diagnostic, Radiology – San Francisco, CA

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding Class II Medical Device Functionality and PET-CT Capabilities

Approval
InterVene: Procedural Device, Thrombectomy, Peripheral Vascular – Redwood City, CA

InterVene Receives FDA 510(k) Clearance for Recana®, the First Fully Integrated Thrombectomy System for Venous In-Stent Restenosis and Native Vessel Obstructions

Product News

BrainCheck: AI, Soft/SaaS, Diagnostic, Cognitive Function – Austin, TX

BrainCheck Expands Normative Database to Further Support Accuracy and Consistency in Cognitive Assessment

Natera: Diagnostic, Liquid Biopsy, Genetic Testing, Oncology, Women’s Health, Transplant – Austin, TX

Natera Announces Expansion to 20 Genes for its Fetal Focus™ Single-Gene NIPT

Breakthrough Devices

Augurex Life Sciences: Diagnostic Test, Axial Spondyloarthritis – Vancouver, BC

Augurex Life Sciences Granted FDA Breakthrough Designation for SPINEstat®, its First-in-Class Diagnostic Test for Axial Spondyloarthritis

Avvio Medical (FKA Applaud Medical): Capital Equip, Lithotripsy System, Urology – San Francisco, CA

Avvio Medical Receives FDA Breakthrough Device Designation for the Avvio Enhanced Lithotripsy System (ELS)

Clinical Trials/Studies

Cleerly: AI, Imaging, Cardiovascular – Denver, CO

TCT 2025 Late-Breaking Science: Quantitative Assessment of Non-Calcified Plaque Volume Drives Risk for Myocardial Infarction and Death

Penumbra: Procedural Device, Thrombectomy, Peripheral Vascular, Neurovascular – Alameda, CA

Landmark STORM-PE Randomized Controlled Trial Finds Computer Assisted Vacuum Thrombectomy (CAVT) with Anticoagulation Superior to Traditional Anticoagulation Treatment for Pulmonary Embolism

Amalgam Rx: AI, Soft/SaaS, EHR, Clinical Decision Support – Wilmington, DE

Amalgam Rx’s Medical-Grade AI™ Doubles Digital Health Engagement—Validated in Peer-Reviewed Studies

Elixir Medical: Procedural Device, IVL, Interventional Cardiology, Interventional Radiology – Milpitas, CA

Elixir Medical Announces Significant Late Breaking Clinical Results for DynamX® Bioadaptor Demonstrating Nearly 50% Reduction in Coronary Event Rates vs. Current PCI Standard of Care

Orchestra Biomed: Procedural Device, Cardiology, Hypertension – New Hope, PA

Orchestra BioMed Announces First Patients Enrolled in Virtue® SAB US Pivotal IDE Coronary Trial

Anteris Technologies: Implant, TAVR, Interventional Cardiology – Brisbane, Australia

Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

Pleural Dynamics: Implant, Automatic Continuous Effusion Shunt System, Thoracic Surgery – Minneapolis, MN

Study Demonstrates Significant Reduction in Pleural Effusion Volume Using Pleural Dynamics’ ACES Fully-Implantable System

Cardiosense: AI, Diagnostic, Cardiology – Chicago, IL

Cardiosense Presents New Clinical Analysis of SEISMIC-HF I Data on AI-Enabled Volume Assessment in Heart Failure at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 Scientific Symposium

Powerful Medical: AI, Diagnostic, Cardiology – Bratislava, Slovakia

AI-Powered Electrocardiogram Improves Heart Attack Detection and Could Help Save Lives Faster, Studies Find

Theranica: Digital Therapeutic, Neuromodulation, Migraine, Neurology – Netanya, Israel

Theranica’s Nerivio® REN Wearable Validated in Landmark 55,000-Patient Study Published in Cephalalgia

Jenscare Scientific: Implant, Transcatheter Heart Valve, Interventional Cardiology – Ningbo, China

Jenscare released its multi-product portfolio’s, including LuX-Valve Plus TRINITY study, JensClip and Ken-Valve, remarkable clinical outcomes at TCT 2025 in the U.S.

Humacyte: Implant, Regenerative Human Tissues – Durham, NC

Humacyte Announces Publication of New Data Comparing Symvess™ to Autologous Vein in Extremity Arterial Trauma

Partnerships

Remedy Robotics: Robotic, Remote Presence, Robotic Intervention, Endovascular, Neurovascular – San Francisco, CA
Mission Thrombectomy: Non-Profit, Outreach Initiative Aimed At Increasing Access To Stroke Care Globally – Washington, DC

Remedy Robotics and Mission Thrombectomy Announce Partnership to Expand Access to Thrombectomy for Stroke with Telerobotics

Guardant Health: Diagnostic Test, Liquid Biopsy, Oncology – Palo Alto, CA
Zephyr AI: AI, Diagnostic, Biomarker, Precision Medicine – McLean, VA

Guardant Health and Zephyr AI Announce Partnership to Unlock Drug Response Predictions and Biomarker Insights

Patents

Light AI : AI, Diagnostic, Infectious Disease – Vancouver, BC

Light AI Expands Patent Portfolio

This & That

Bioretec : Implant, Absorbable, Orthopedic Surgery – Tampere, Finland

Inside information: Bioretec is revising its financial targets, deems that the current financial targets will not be met and withdraws its financial targets

Aztron Medtech: Procedural Device, Achilles Tendon Repair, Foot & Ankle Surgery – Taipei City, Taiwan

Aztron Medtech and Lovell Government Services Secure FSS, ECAT and GSA Listings, Expanding U.S. Government Access to TendMIN™ Achilles Tendon Repair System

About Stiffler Search Group

Stiffler Search Group was founded in 2009 by Dan Stiffler, a seasoned veteran in medical industry recruiting. Our work is performed on retainer or contingency. We work with companies of all sizes, but our passion lies in representing early-stage MedTech companies, with a focus on procedural devices and capital equipment. If you would like to discuss a potential search, click here. If you would like to engage with us as a candidate, please submit your resume for consideration.

About MedTech Startup Roundup

We bring you the latest news on early-stage companies, people, and products driving innovation in the MedTech industry via the MedTech Startup Roundup. Our publication is a compilation of news from multiple sources, encompassing a broad range of topics. The focus is on North American companies. We also cover young, publicly traded companies and similar companies from other countries with business activities in North America. We hope you find it helpful and share it with your associates!

MedTech Startup Roundup’s sources of information include: PR Newswire, Business Wire, Crunchbase, PitchBook, The SaaS News, European Investment Bank, LinkedIn, Yahoo Finance, Pulse 2.0, Globe Newswire, PRWeb, Morningstar, Yahoo, Cision, Medical Product Outsourcing, citybiz, FINSMES, Fierce Biotech, Stocks Down Under, Fox News, HIT Consultant, Newswire, Investing, Access Newswire, MedicalXpress, Reuters, BioSpace, Tracxn, CHI, Division of Cambridge Healthtech Institute, Seeking Alpha, and medical company websites.

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