MedTech Startup Roundup – Vol.1 No.30

The news you need on MedTech startups

Dan’s Picks

Nephrodite: Implant, Renal Dialysis – Continuous – Atlanta, GA

Nephrodite Earns FDA’s First Breakthrough Device Designation for an Implantable Kidney Replacement System

CCS: Diabetes Supplies – St. Petersburg, FL

Landmark Study Reveals CGM Use Among Insulin-Dependent Diabetes Patients Reduces Healthcare Costs by 20% While Improving Clinical Outcomes—Yet 80% of Eligible Patients Still Not Using The Technology

Medivis: AI, AR, Navigation, Spine Surgery – New York, NY

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

athenahealth: AI, Soft/SaaS, EMR, Pt. Engagement, Practice Mgt. – Boston, MA

New Findings From athenahealth Reveal AI Use Advancing Beyond Administrative Tasks to Clinical Decision-Making Support

Ventric Health: Diagnostic, Equip, Non-Invasive, Heart Failure in PC Setting – Pasadena, CA

New Study Establishes Vivio System as First Technology to Accurately Measure LVEDP Non-Invasively

Hello!

Lotus Neuro: Precision Medicine, Ultrasound, Brain Health, Neurology – Miami, FL

Insightec Announces Spin-Out of Lotus Neuro to Advance Focused Ultrasound Brain Therapies

NeuraWorx Medical Technologie: Wearable, Bioelectronic, Brain Health – Excelsior, MN

Product Launches

Infinitus Systems: AI, Voice Agents – San Francisco, CA

Infinitus Launches Next-Generation Clinical AI Agents

Huxley Medical: Diagnostic, Sleep Apnea – Atlanta, GA

Huxley Medical Announces Commercial Launch of FDA-Cleared Central Sleep Apnea Detection and Appointment of Medical Director of Sleep Medicine

MARAbio Systems: Diagnostic Test, Autism – Salt Lake City, UT

MARABIO LAUNCHES FIRST-EVER BLOOD TEST FOR MATERNAL AUTOANTIBODY RELATED AUTISM

Smart Meter: Remote Pt. Monitoring, Predictive Medicine – Tampa, FL

Smart Meter Introduces First Handheld Cellular-Connected Thermometer for Effortless Patient Monitoring

b.well: AI, Soft/SaaS, Data Integration – Baltimore, MD

b.well Launches the First-Ever SDK for Health AI Assistants

M&A

Acquisition
SpectraWAVE: AI, Imaging, Cardiovascular – Bedford, MA
Philips: Multiple Product Lines – Amsterdam, Netherlands

Philips agrees to acquire SpectraWAVE Inc., advancing next-generation coronary intravascular imaging and physiological assessment with AI

Acquisition
Zapoj: AI, Soft/SaaS, Critical Event Mgt – Gannavaram, India
Juvare: AI, Soft/SaaS, Critical Event Mgt – Atlanta, GA

Juvare Acquires Zapoj Expanding Its Leadership in Critical Event Management and Visual Risk Intelligence

The Cs

DexCare: Soft/SaaS, Pt. Scheduling, Pt. Navigation – Seattle, WA

Rakshay Jain – CPO – Product (Joining)

DexCare Hires Rakshay Jain as Chief Product Officer to Advance its Patient Navigation Platform That Cuts Wait Times by 5 Days

KORU Medical Systems: Device, Disposable, Drug Delivery – Mahwah, NJ

Eric Schiller – CTO (Joining)

KORU Medical Systems, Inc. Appoints Eric Schiller as Chief Technology Officer

AVeta Medical: DME, GSM Treatment, Women’s Health – Galway, Ireland

Karen Noblett – CEO (Promotion)

AVeta Medical Appoints Karen Noblett as New CEO

Board Members

ENvue Medical: Navigation, Minimally Invasive, Tibe Feeding Placement – Tyler, TX

David Johnson – Chairman of the Board (Joining)

ENvue Medical Appoints Veteran Healthcare-Industry Executive, David Johnson, as Chairman

OsteoCentric Technologies: Implant, Procedural Device, Orthopedic Surgery, Sports Med Surgery – Austin, TX

RJ Brideau – Board Member (Additional Responsibility)

OsteoCentric Technologies Appoints RJ Brideau to Board of Directors

AVeta Medical: DME, GSM Treatment, Women’s Health – Galway, Ireland

Eileen Duffy – Chairman of the Board (Transitioning)

AVeta Medical Appoints Karen Noblett as New CEO

Relief Cardiovascular: Implant, Transvascular, Diagnostic, Therapeutic, CHF – Costa Mesa, CA

Harry Rowland – Chairman of the Board (Joining)

Relief Cardiovascular Appoints Harry Rowland as Chairman of the Board

Funding

Auxira Health: Service, Connected Care, Cardiology – Chicago, IL

Auxira Health Raises $7.8 Million to Redefine How Cardiology Teams Deliver Care

Prospyr Medical: Soft/SaaS, Practice Mgt, Aesthetics – Austin, TX

Prospyr Announces Strategic Growth Investment from Five Elms Capital

Cofactor Genomics: ML, Diagnostic, Predictive Medicine, Cancer – San Francisco, CA

Cofactor Genomics Announces Strategic Investment by Labcorp and Ascension Ventures to Fuel Expansion of Its OncoPrism® Immunotherapy Diagnostic Across U.S. Cancer Care Networks

Amferia: Disposable, Infection Control – Mölndal, Sweden

Medtech Firm Amferia Secures €3.5M Investment to Accelerate Breakthrough Antimicrobial Technology in Human and Animal Health

BVLASER: Laser, Aesthetic – Nanjing, China

With hundreds of millions of yuan in funding, BVLASER completes Series C financing round, accelerating global expansion and technological innovation

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

Inspira Announces $1.8 Million Registered Direct Offering Priced At-The-Market and Additional Equity Financing Agreement to Support Ongoing Commercial Execution

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

Agitated Solutions Announces W. L. Gore & Associates Joins Series B Investment Syndicate

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

Aussie medtech Ferronova raises another $6 million to advance image-guided cancer surgery

Leona Health: AI, Soft/SaaS, AI Assistant via WhatsApp – Mexico City, Mexico

Leona Health Launches the World’s First AI Co‑Pilot for Doctors through WhatsApp

Cosán Group: AI, Virtual Medicine – Cleveland, OH

Cosan Secures Strategic Growth Investment to Scale AI-Enabled, Team-Based Virtual Care for Chronic Conditions

CranioSense: Monitor, Non-Invasive, ICP, Neurology – Bedford, MA

CranioSense Awarded $5.5 Million in Federal Grants to Validate Noninvasive Neurotech

Ultromics: AI, Diagnostic, Cardiology – Oxford, UK

Ultromics Secures Strategic Investment from the American Heart Association’s Go Red for Women Venture Fund™

Drive Health: AI, Soft/SaaS, Agentic Nursing – Gilbert, AZ

Vitalis Ventures Announces $15 Million Strategic Funding for Drive Health to Accelerate Avery, the Clinical Workflow AI

Tebra: AI, Soft/SaaS, Clinical Documentation – Corona Del Mar, CA

Private Practice Platform Tebra Secures $250M to Accelerate AI Innovation

Wearlinq: Remote Medicine, ECG, Cardiology – San Francisco, CA

Wearlinq Raises $14M to Combat America’s Leading Cause of Death with the First and Only Wireless 6-Lead Cardiac Monitor

CMR Surgical: Robotics, Surgical – Cambridge, UK

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

NeuraWorx Medical Technologie: Wearable, Bioelectronic, Brain Health – Excelsior, MN

NeuraWorx Closes Oversubscribed Seed Round Led by Nexus NeuroTech to Advance Neurotechnology Therapy for CNS Disorders

Regulatory

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

Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System

PMA
Companion Spine: Implant, Spine Surgery – Mérignac, France

Companion Spine Announces FDA Premarket Approval (“PMA”) of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease (“DDD”)

Approval
AZmed: AI, Software/SaaS, Imaging, Chest – Paris, France

AZmed Expands Into CT Imaging With CE-Marked AZnod, An AI Tool for Lung Nodule Detection and the First Product in the Rayscan® Line

Submittal
Spinol Medical: Implant, Annular Closure, Spine Surgery – Modiin-Maccabim-Reut, Israel

Spinol Medical™ Advances OctaSeal™ Into FDA Review — A Minimally Invasive, Intradiscal Annular Closure Technology Backed by Five-Year Clinical Data

Approval
May Health: Procedural Device, PCOS, Gynecology – Paris, France

May Health Announces CE Mark for Innovative Treatment for Women with PCOS-related Infertility

Approval
BlueWind Medical: Neuromodulation, Tibial, Urology, Urgency Urinary Incontinence – Tel Aviv, Israel

BlueWind Medical Receives FDA 510(k) Clearance for Enhanced Revi® Wearable Supporting Long-Term Treatment of Urgency Urinary Incontinence

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

RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit

Approval
Medivis: AI, AR, Navigation, Spine Surgery – New York, NY

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

Approval
Zephyrus Innovations: Disposable, Safety Syringe – Vancouver, BC

Zephyrus Innovations™ announces US FDA 510(k) clearance for VaporShield™ CSTD

Approval
Spinal Simplicity: Implant, Spine Surgery, SI Joint – Overland Park, KS

Spinal Simplicity Announces FDA Clearance of Minuteman® G6 MIS Fusion Device

Approval
SleepRes: DME, KPAP, Sleep Apnea, Pulmonary – Murfreesboro, TN

SleepRes Receives FDA Clearance for its Kricket™ Positive Airway Pressure (PAP) Device with KPAP™

Approval
Huxley Medical: Diagnostic, Sleep Apnea – Atlanta, GA

Huxley Medical Announces Commercial Launch of FDA-Cleared Central Sleep Apnea Detection and Appointment of Medical Director of Sleep Medicine

Approval
CMR Surgical: Robotics, Surgical – Cambridge, UK

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

Approval
Pearl: AI, Imaging, Dental – West Hollywood, CA

Pearl Expands Dental AI Capabilities with FDA Clearance for Panoramic X-Rays

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

Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation

Approval
Caretaker Medical: Pt. Monitoring, Wireless – Charlottesville, VA

Caretaker Medical Wins FDA Clearance for VitalStreamART, Delivering Non-Invasive & Arterial Line Hemodynamic Monitoring

Product News

OrthAlign: Navigation, Hand-Held, Orthopedic Surgery – Irvine, CA

OrthAlign Expands Lantern® Hip Platform to Support Posterior-Based Surgical Approaches in Total Hip Arthroplasty

Eon Health: AI, Soft/SaaS, Pt. Mgt, Cancer Risk , Validation – Denver, CO

Eon Launches 5.0 Platform to Address Healthcare’s Growing ‘Validation Burden’

Breakthrough Devices

Nephrodite: Implant, Renal Dialysis – Continuous – Atlanta, GA

Nephrodite Earns FDA’s First Breakthrough Device Designation for an Implantable Kidney Replacement System

Clinical Trials/Studies

Cleerly: AI, Imaging, Cardiovascular – Denver, CO

CVCT 2025: Cleerly Late-Breaking Science Identifies Thresholds of High Plaque Burden in Non-Obstructive CAD that May Carry Greater Risk Than Obstructive Disease

Medical 21: Implant, Cardiovascular Graft, Cardiovascular Surgery – Minneapolis, MN

Medical 21, Inc. Announces Regulatory Approval to Initiate First-in-Human Clinical Study in Spain

Thermedical: Procedural Device, Ablation, E-P, Cardiology – Weston, MA

Thermedical Announces First Patient Treated in Pivotal Clinical Study Evaluating SERF Ablation for Life-Threatening Ventricular Tachycardia

Nucleix: Diagnostic, Liquid Biopsy, Cancer, Urology, Pulmonology – Rehovot, Israel

A Study Published in European Urology Oncology Demonstrated Bladder EpiCheck® Can Detect High-Grade Bladder Cancer Recurrences Missed by White Light Cystoscopy

CCS: Diabetes Supplies – St. Petersburg, FL

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

I-SPY 2 Publication in Nature Communications Shows Signatera™ Can Predict Treatment Response and Recurrence Risk in Early-Stage Breast Cancer

Cofactor Genomics: ML, Diagnostic, Predictive Medicine, Cancer – San Francisco, CA

Cofactor Genomics Advances Predictive Cancer Diagnostics With Landmark OncoPrism-NSCLC Study

Personalis: Diagnostic Test, Liquid, Breast – Fremont, CA

Personalis Announces New Publication Applying Ultrasensitive ctDNA Testing to Monitoring Cancer Immunotherapy Response Across Solid Tumors

ALZpath: Diagnostic Test, Alzheimer’s, Neurology – Carlsbad, CA

ALZpath-Powered Blood Test Enables Landmark Study on Growing Alzheimer’s Disease Prevalence

MiraDx: Diagnostic, Molecular, Radiation Therapy for Prostate Cancer – Los Angeles, CA

New Publication Shows PROSTOX™ ultra Test Delivers Significant Health System Cost Savings and Quality-of-Life Gains for Prostate Cancer Patients Undergoing Radiation Therapy

Ventric Health: Diagnostic, Equip, Non-Invasive, Heart Failure in PC Setting – Pasadena, CA

New Study Establishes Vivio System as First Technology to Accurately Measure LVEDP Non-Invasively

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

Natera Announces Publication of Signatera™ Analysis from Randomized, Phase III CALGB (Alliance)/SWOG 80702 Study in Colorectal Cancer

Linus Health: Diagnostic, Digital Health, Neurology, Cognitive Health – Boston, MA

Peer-Reviewed Studies Validate Linus Health AI as an Early Digital Biomarker for Alzheimer’s Pathology, Helping People Take Action Earlier to Slow Disease Impact

Partnerships

Surglogs: Soft/SaaS, Regulatory, Accreditation – Coronado, CA
HST Pathways: Soft/SaaS, ASC Operations – Nashville, TN

HST Pathways and Surglogs Establishes Partnership to Enhance Paper-Free Compliance and Survey Readiness for ASCs

This & That

Detect-ION: Diagnostic, POC Test, Molecular – Tampa, FL

Detect-ION Launches Collaborative Project to Develop Breath-Based Diagnostics for Pneumonia-Causing Pathogens

Motif Neurotech: Implant, BCI, Depression, Neurosurgery, Mental Health – Houston, TX

Motif Neurotech Launches Patient Registry for Future Research Opportunities

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

Heartflow Plaque Analysis Now Supported by Scientific Statements From American College of Cardiology and American Heart Association for Personalized Management of Patients with Suspected CAD

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.