MedTech Startup Roundup – Vol.1 No.22

The news you need on MedTech startups

Dan’s Picks

Rhythio Medical: Injectable, Defibrillator – Houston, TX

Rhythio Medical Receives FDA Breakthrough Device Designation for Injectable Electrode Technology Enabling Painless, Imperceptible Defibrillation

Product Launches

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

Viz.ai Launches Viz Assist: The First Multimodal AI Agent Platform for Faster Treatment and Better Outcomes

Bayou Surgical: Procedural Device, Automated Laparoscope Cleaning – Houston, TX

Bayou Surgical Introduces Next-Generation 5 mm troCarWash™ System for Automated Laparoscope Cleaning

hc1: Soft/SaaS, Data Analysis, Laboratory Data – Indianapolis, IN

hc1 Launches hc1 IQ™, a Groundbreaking AI-Powered Intelligence Platform to Revolutionize Healthcare, at HLTH 2025

Podimetrics: Remote Pt. Monitoring, Diabetic Complications – Somerville, MA

Podimetrics Launches SmartMat+ to Save Limbs, Reduce Falls, and Monitor Signs of Heart Failure in Complex Diabetes

Cedar: AI, Soft/SaaS, Financial – New York, NY

Cedar Launches Cedar Cover to Help Hospitals Navigate the Medicaid and Affordability Crisis

Oshi Health: Telemedicine, Gastroenterology – New York, NY

Oshi Health Launches Access+ to Help GI Practices Expand Capacity, Boost Revenue and Retention, and Improve Patient Outcomes

Eleos: AI, Soft/SaaS, Medicaid Eligibility, Post-Acute Care, Mental Health – Boston, MA

Eleos to Launch Polaris AI Advanced, Purpose-Built Foundational AI Model for Post-Acute Care, built with Google Cloud Technology

Praia Health: Soft/SaaS, Patient Conversion – Chicago, IL

Praia Health Launches Praia Intelligence, Driving 30% Patient Lead Conversion Lift Across Health Systems

CorVent Medical: AI, ML, Capital Equip, Respirator, Pulmonology – Fargo, ND

CorVent Medical Launches AI/ML-Driven CorVision™ SaaS Platform and Opens Series B Financing

Ampa Health: Capital Equip, TMS, Neurology, Mental Health – Palo Alto, CA

Ampa Launches Nationwide Rollout of Portable FDA-Cleared Brain Stimulation System Following $8.5M Oversubscribed Funding Round

iNPLANT: Procedural Device, Breast Implant Delivery – Allendale, NJ

iNPLANT LLC Launches XL Funnel: The First “No-Touch” Delivery System for Large Breast Implants

Heartflow: AI, Imaging, Cardiology – Mountain View, CA

New Heartflow PCI Navigator to Equip Interventional Cardiologists with Pre-procedural Insights to Enable PCI Planning

Aerin Medical: Procedural Device, ENT – Mountain View, CA

Aerin Medical Launches Next-Generation Device for Chronic Rhinitis Relief

The Cs

Kandu, Inc.: Rehabilitation, Stroke – Van Nuys, CA

Nabeel Ahmed – CFO (Joining)

Kandu, Inc. Announces Expansion of Executive Leadership Team and Board of Directors

epiminder: Implant, Continuous EEG – Melbourne, Australia

Mark McLellan – CFO (Joining)

Epiminder Announces Appointment of Mark McLellan as Chief Financial Officer

Tellihealth: Soft/SaaS, Remote Pt. Monitoring, Chronic Care Mgt – Houston, TX

Chuck Washburn – CRO – Revenue (Joining)

Tellihealth Appoints Chuck Washburn as Chief Revenue Officer to Accelerate Growth and Strengthen Provider Partnerships

Board Members

Kandu, Inc.: Rehabilitation, Stroke – Van Nuys, CA

Bret Christensen – Board Member (Joining)
Michael Levitz – Board Member (Joining)

Kandu, Inc. Announces Expansion of Executive Leadership Team and Board of Directors

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

Robert Cartagena – Board Member (Joining)
Mario Vetro – Board Member (Joining)

Light AI announces New Director Appointments

Rune Labs: Soft/SaaS, Precision Medicine, Neurology – San Francisco, CA

Adam Pellegrini – Board Member (Joining)

Rune Labs Appoints Digital Health Leader Adam Pellegrini to Board of Directors

Inspira Technologies: Capital Equipment, Pulmonology, Acute Respiratory Support – Ra’anana, Israel

Sivan Matza – Board Member (Joining)

Inspira Appoints Former Johnson & Johnson Senior Business Manager as VP of Global Sales and New Board Member from a Leading International Investment Firm

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

Eric Fain, MD – Board Member (Joining)

Berlin Heals Welcomes Dr. Eric Fain as New Board Member

Catalyst OrthoScience: Implant, Orthopedic, Shoulder – Naples, FL

Theodore Blaine, MD – Board Member (Joining)

Catalyst OrthoScience Secures $15.0 Million in Growth Financing

Epica International: Capital Equip, Robotics, Imaging – Landrum, SC

Alok K. Agrawal – Board Member (Joining)

Epica International Appoints Alok K. Agrawal to Its Board of Directors

AngioInsight: AI, Soft/SaaS, Imaging, Angiographic Interpretation – Minnetonka, MN

Shlomi Nachman – Board Member (Joining)

AngioInsight Appoints Medtech Veteran Shlomi Nachman to Board of Directors; Announces Series A Round to Accelerate AI-Driven Advancement in Cardiology

Cardiawave: Ultrasound Therapy, Non-Invasive, Aortic Stenosis, Cardiology – Levallois-Perret, France

Jonathan Freeman – Chairman of the Board (Promotion)

Cardiawave Strengthens Leadership with Appointment of Jonathan Freeman as Board Chairman

Funding

Cleveland Diagnostics: Diagnostic, Liquid Biopsy, Prostate Cancer, Urology – Cleveland, OH

Cleveland Diagnostics raised $14,421,653

VerAvanti: Imaging, Intravascular, Scanning Fiber Endoscope – Bothell, WA

Middle East Family Office Invests $5M in VerAvanti, Securing Exclusive Regional Distribution Rights for SFE Technology

Spark Biomedical: Wearable, Neurostimulation, Opioid Withdrawal – Dallas, TX

Spark Biomedical Awarded an NIH Grant to Study the Treatment Effects of tAN® for Alcohol Withdrawal Symptoms

Grail: Diagnostic, Oncology, Precision Medicine – Menlo Park, CA

GRAIL, Inc. Announces $325.0 Million Private Placement Financing

Adaptyx Biosciences: Biowearable, Diagnostic, Molecular Monitoring, Continuous – Menlo Park, CA

Adaptyx Raises $14M in Seed Financing to Launch Wearable Platform for Continuous Multi-Analyte Molecular Monitoring

CoMind: Diagnostic, Neurologic Monitoring, Continuous – London, UK

CoMind announces $102.5m funding to redefine clinical monitoring of the brain

Owlet: DME, Baby Monitor – Lehi, UT

Owlet, Inc. Announces Proposed Public Offering of Class A Common Stock

RIVANNA: AI, Imaging, Ultrasound, Soft/SaaS, Anesthesia – Charlottesville, VA

RIVANNA awarded $3 million CDMRP grant to develop military-optimized ultrasound guidance system for spinal interventions

Burl Concepts: Imaging, Ultrasound, Neurovascular – San Diego, CA

BURL CONCEPTS CLOSES CURRENT OVERSUBSCRIBED $4.5 MILLION INVESTMENT

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

Median Technologies Receives €19 Million From the European Investment Bank, Corresponding to the First Tranche Under the 2025 Loan Facility

Catalyst OrthoScience: Implant, Orthopedic, Shoulder – Naples, FL

Catalyst OrthoScience Secures $15.0 Million in Growth Financing

Ampa Health: Capital Equip, TMS, Neurology, Mental Health – Palo Alto, CA

Ampa Launches Nationwide Rollout of Portable FDA-Cleared Brain Stimulation System Following $8.5M Oversubscribed Funding Round

CND Life Sciences: Diagnostic Test, Neurodegenerative – Scottsdale, AZ

CND Life Sciences Announces NIH Grant to Study the Risk of Parkinson’s Disease in Patients with Essential Tremor

Newton AI: AI, Soft/SaaS, Workflow Automation, Dental – San Francisco, CA

Newton Raises $3.8M to Grow AI-Native Workflow Platform for Dental Practices

Pensievision: Diagnostic, 3D Imaging, Gynecology – San Diego, CA

Governor Hochul Announces Winners of Round Eight of Luminate NY OPI Accelerator Competition

ENDRA Life Science: Diagnostic, Imaging, Hepatology, NASH, – Ann Arbor, MI

ENDRA Life Sciences Closes Up to $14.4 Million Private Placement and Launches Crypto Treasury Strategy with $3 Million in Initial HYPE Token Holdings

AngioInsight: AI, Soft/SaaS, Imaging, Angiographic Interpretation – Minnetonka, MN

AngioInsight Appoints Medtech Veteran Shlomi Nachman to Board of Directors; Announces Series A Round to Accelerate AI-Driven Advancement in Cardiology

Spectral AI: AI, Imaging, Wound Care – Dallas, TX

Spectral AI raises $7.6 Million of Additional Growth Capital

Polyembo: Procedural Device, Vascular Embolization – Longmont, CO

Polyembo Closes Funding to Commercialize New Vascular Embolic Technology

ONWARD Medical: Implant, BCI, Neuromodulation, Spinal Cord – Eindhoven, The Netherlands

ONWARD Medical Successfully Raises Over EUR 50 Million in Capital Increase

Regulatory

Approval
ManaMed: DME, SCD, Orthotics, TENS – Denton, TX

ManaMed® Secures FDA 510(k) Clearance for PlasmaFlow® X — a Breakthrough, Compact Sequential Compression System with All-Day Battery

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

Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology

Approval
Access Vascular: Disposable, Midline I-V Catheter – Billerica, MA

FDA Clears Access Vascular HydroMid® and HydroPICC® Catheters With Anti-Thrombogenic Indication

Approval
SpectraWAVE: AI, Imaging, Cardiovascular – Bedford, MA

SpectraWAVE Receives 510(k) Clearance for X1™-FFR, an AI-enabled, Wire-Free, Drug-Free, Single Angiogram Physiology Solution

Approval
Mesh Suture: Procedural Device, Mash Suture – Chicago, IL

Mesh Suture, Inc. Secures Key Regulatory Approvals, Accelerating Global Access to DURAMESH™ for Surgeons Worldwide

Approval
Qure.ai: AI, Soft/SaaS, Clinical Diagnosis, Pt. Care Coordination – Mumbai, India

Qure.ai Continues Pace of US Growth With 19th FDA Clearance

Approval
Mode Sensors: Wearable, Fluid Mgt – Oslo, Norway

Mode Sensors Receives FDA 510(k) for Fluid Monitoring System

Approval
Alife Health: Diagnostic, Service, IVF – San Francisco, CA

Alife Health Receives CE Mark Under European Medical Device Regulation for Embryo Predict™, Its AI-Powered Embryo Selection Tool

Submittal
Protaryx Medical: Procedural Device, Transseptal Puncture, Cardiac Surgery, Interventional Cardiology – Baltimore, MD

Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device

Approval
YorLabs: Imaging, Intracardiac Imaging, EP, Interventional Cardiology – Beaverton, OR

YorLabs Announces FDA 510(k) Clearance of its Zero-CapEx Intracardiac Imaging System

Product News

Solenic Medical: Capital Equipment, Infection Control, Orthopedic Implants – Addison, TX

Solenic Medical Announces Successful Use of Its AMF Technology Under FDA Compassionate Use Authorization

Evenly Orthodontics: AI, Telemedicine, Orthodontic – Washington, DC

Evenly Orthodontics Expands Its Virtual-First Model With At-Home Check-Ins And Nationwide Reach

Breakthrough Devices

GeneDx: Diagnostic Test, Genetic, Precision Medicine – Stamford, CT

GeneDx Granted FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ Testing

Rhythio Medical: Injectable, Defibrillator – Houston, TX

Rhythio Medical Receives FDA Breakthrough Device Designation for Injectable Electrode Technology Enabling Painless, Imperceptible Defibrillation

Fast Track Designation

Agitated Solutions: Imaging, Ultrasound, Image Enhancement, Cardiology – Saint Paul, MN

Agitated Solutions, Inc. Receives Fast Track Designation for Investigational Drug ASI-02

Clinical Trials/Studies

Science Corporation: Implant, BCI, Retinal – Alameda, CA

Science Corp.’s PRIMA BCI Implant Restores Functional Central Vision to Patients with Geographic Atrophy Caused By Age-Related Macular Degeneration, a Leading Cause of Blindness, The New England Journal of Medicine Reports

Delve Bio: Diagnostic, Infectious Disease – San Francisco, CA

New Data Show Early Use of Delve Bio’s Metagenomic Testing Can Reduce Need for Conventional Tests and Overall Length of Stay for Patients with Meningitis/Encephalitis

IMVARIA: AI, Diagnostic, Digital Biomarker, Lung, Pulmonology

IMVARIA’s AI-Powered, Non-Invasive Bronchosolve Solution Meets Primary Endpoints for Lung Cancer Diagnosis in Pivotal VIRTUAL-BRONCH Study

Brainomix: AI, Imaging, Neurovascular, Stroke, Pulmonary – Oxford, UK

Brainomix e-Lung Enables Earlier Detection of Progressive Pulmonary Fibrosis, New Study Shows

Mentavi Health: Diagnostic, Mental Health – Grand Rapids, MI

Peer-Reviewed Journal of Clinical Psychiatry Publishes Mentavi’s Online ADHD Diagnostic Evaluation Validation Study

Raydiant Oximetry: Diagnostic, Fetal Monitoring – San Ramon, CA

Raydiant Oximetry Successfully Completes 35-Patient Early Feasibility Study at Eastern Virginia Medical School

GT Medical Technologies: Procedural Device, Radiation Therapy, Brain, Neurosurgery – Tempe, AZ

Breakthrough clinical trial confirms that GammaTile delivers superior tumor control compared to standard of care for patients with newly diagnosed operable brain metastases

Subtle Medical: AI, Imaging, MRI – Menlo Park, CA

Subtle Medical Announces Positive Findings from Proof-of-Concept Study with Bayer Investigating AI To Lower Gadolinium Dose in CE-MRI

Cairn Surgical: Imaging, Guided Surgery, Localization, Surgical Oncology – Lebanon, NH

New Published Data Shows Breast Cancer Locator System Dramatically Improves Surgeon Ability to Remove Entire Tumor With Negative Margins

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.

Hyperfine: AI, Imaging, MRI, Portable – Guilford, CT

Hyperfine Announces First Patients Enrolled in PRISM PMR to Evaluate the Use of Next-Generation Swoop® System in the Operating Room Setting

Nyra Medical: Implant, Transcatheter, Heart Valve – Atlanta, GA

Nyra Medical Announces Initiation of First-in-Human Clinical Trial for Novel Mitral Valve Repair Device

Geneoscopy: Diagnostic Tests, Gastroenterology, Colorectal Cancer Screening Test – St. Louis, MO

Geneoscopy’s Scrape-Free Collection Method for Colorectal Cancer Screening Validated by New Data and Peer-Reviewed Publication

CND Life Sciences: Diagnostic Test, Neurodegenerative – Scottsdale, AZ

CND Life Sciences Announces NIH Grant to Study the Risk of Parkinson’s Disease in Patients with Essential Tremor

Emboline: Procedural Device, Embolic Protection, Interventional Cardiology – Santa Cruz, CA

Emboline, Inc. Completes Enrollment in U.S. Pivotal IDE Trial of the Emboliner® Embolic Protection Catheter Designed to Protect Patients from Embolic Injury During Transcatheter Aortic Valve Replacement

Ancora Heart: Procedural Device, Transcatheter, Heart Failure – Santa Clara, CA

Ancora Heart Inc. Reports Two-Year Results Demonstrating Sustained Benefits of AccuCinch® System in Heart Failure Patients

Ladera Medical: Procedural Device, Femoral Closure, Interventional Radiology, Interventional Cardiology – Baltimore, MD

Cordis-X Advances FASTEN Trial for Ladera Large Bore Closure System

Neocis: Robotic, Implant, Dental, Oral Surgery – Miami, FL

New Clinical Data Confirms Yomi® Robotic System Enhances Efficiency in Dental Implant Surgery

Pulse Biosciences: Procedural Device, Bioelectric Medicine, PFA, Oncology, Cardiology – Hayward, CA

Pulse Biosciences Announces First Enrollment in the NANOCLAMP AF Study

Laplace Interventional: Implant, Transcatheter Heart Valve, Interventional Cardiology – Plymouth, MN

Laplace Interventional completes Trans-Jugular US Early Feasibility Study and adds Trans-Femoral approach

Cardiovalve: Implant, Transcatheter Heart Valve, Interventional Cardiology – Or Yehuda, Israel

Cardiovalve Completes TARGET Study Enrollment for CE Registration Study for Tricuspid Valve Replacement

SetPoint Medical: Implant, Neuroimmune Modulation – Valencia, CA

SetPoint Medical to Present Data at ACR Convergence 2025 Demonstrating Sustained Efficacy and Safety for the SetPoint System to Treat Rheumatoid Arthritis

Jupiter Endovascular: Procedural Device, Endovascular, Embolization – Menlo Park, CA

Jupiter Endovascular Announces Positive Results From SPIRARE I First-in-human Study Presented at TCT 2025

Egg Medical: Radiation Protection System – Arden Hills, MN

Real-World Data Presented at TCT 2025 Demonstrates the EggNest™ Complete Radiation Protection System Significantly Reduces Radiation Exposure for the Entire Cath Lab Team

Partnerships

Arthrolense: ML, Surgical Guidance – Toronto, ON
Waldemar Link: Implant, Orthopedic Surgery – Hamburg, Germany

Arthrolense and Waldemar Link Form Strategic Agreement to Advance Machine Vision-Enabled Orthopedic Surgery

Patents

Prevencio: AI, Diagnostic, Blood Test, CAD – Kirkland, WA

Prevencio Awarded Additional Patents for HART CADhs, Its AI-Driven Blood Test for Coronary Artery Disease

This & That

Wearables Startups Are Having A Moment

Overture Life: AI. Robotics, Capital Equip, IVF, Fertility – Alcobendas, Spain

Overture Life Opens First U.S. Clinical Lab and Operations Hub in Dallas as AI-Powered IVF Robotics Headquarters

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.

**The information provided is news on the web and should NOT be used for investment or career purposes without your due diligence.