MedTech Startup Roundup – Vol.2 No.15

The news you need on MedTech startups

Dan’s Picks

Tairex Technology: AI, Virtual Hospital – Beijing, China

Tairex Launches Virtual Consultation Room, Setting A New Paradigm for AI Medical Services

Hello!

SonoNeu: Therapeutic, Ultrasound, Controlling Tapped Cell – Palo Alto, CA

SonoNeu exits stealth as key part of US Government-funded research program worth up to $41.3m to advance sonogenetics into clinic

Product Launches

Egg Medical: Surgical Radiation Protection – Arden Hills, MN

Egg Medical Launches EggNest™ Complete Flex: Apron-Free Protection Without Construction, Downtime or Disruption

FacialDx: AI, Diagnostic, Health Evaluation – Orange Park, FL

FacialDx Launches AI Facial Analysis Platform for Regenerative Medicine Providers with Free Trial Access

IKS Health: AI, Soft/SaaS, Workflow, Prior Auth, Claims – Mumbai, India & Dallas, TX

IKS Health Announces Launch of Audit-Ready Autonomous Coding Capabilities

Neuromod Devices: Neuromodulation, ENT, Tinnitus – Dublin, Ireland

Lenire Tinnitus Treatment Device Now Available in Canada

Smarter Technologies: AI, Soft/SaaS, Revenue Cycle Mgt – Dallas, TX

Smarter Technologies Expands AI Revenue Cycle Platform with Launch of SmarterUtilization

Waystar: AI, Soft/SaaS, RCM – Louisville, KY

Waystar Introduces Industry’s First AI Solution Addressing Widespread “Silent Denials” from Payer Payment Take-Backs

Penguin AI: AI, Soft/SaaS, Back-Office Workflow – Palo Alto, CA

PENGUIN AI LAUNCHES PRIOR AUTHORIZATION AND MEDICAL CODING SOLUTIONS AS SNOWFLAKE NATIVE APPS ON SNOWFLAKE MARKETPLACE

Cedar: AI, Soft/SaaS, Billing, Reimbursement – New York, NY

Cedar Expands AI-Powered Personalization in Healthcare Billing With New Cedar Intelligence Capabilities

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

Pearl Introduces Ambient Voice AI Suite for Dentistry

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

Rune Labs Launches Parkinson’s AI Companion Trained on the World’s Largest Parkinson’s Dataset

SPRY Therapeutics: AI, Soft/SaaS, Pt. Scheduling – Pune, India

SPRY Launches First AI Scribe Agent Built Natively for Rehab Therapy: Learns Clinician Preferences, Carries Full Patient History, and Drives 80% Therapist Retention

REEV: Robotic, Orthosis, Post-Stroke Walking – Toulouse, France

REEV Launches Neuro-Integration Program with Leading Stroke Rehabilitation Centers

Ataraxis AI: Diagnostic, Predictive, Precision Medicine – New York, NY

Ataraxis AI Launches Ataraxis Breast NEO, a New AI Test Predicting Response to Neoadjuvant Therapy in Breast Cancer

My Gene Counsel: AI, Diagnostic, Genetic Testing, Digital Medicine, Precision Medicine – New Haven, CT

My Gene Counsel Launches Precision Medicine Pilot at Pacific Cancer Care Leveraging N-Power Medicine’s Point-of-Care Platform to Expand Access to Guideline-Based Genetic Testing

Plenful: AI, Soft/SaaS, Workflow Automation, Pharmacy – San Francisco, CA

Plenful Unveils MFP “Command Center” to Help Health Systems Recover Up to 20% in Missing Medicare Drug Price Refunds

Robotimize: Robotic, Neurorehab – Singapore

Robotimize Announces U.S. Market Entry with HandVivante™ MirrorHand, Expanding Access to Data-Enabled Neurorehab

Solv: AI, Soft/SaaS, Operating System, Medical Practice – Oakland, CA

Solv Launches AI-First Operating System for Providers to Deliver Increased Access and Price Transparency to Meet Rising Consumer Expectations

Substrate AI : AI, Agent, RCM – San Francisco, CA

Substrate AI Launches the Substrate Claim Status Agent, Delivering Industry-First AI-Native Solution for Claims Monitoring

Tairex Technology: AI, Virtual Hospital – Beijing, China

Tairex Launches Virtual Consultation Room, Setting A New Paradigm for AI Medical Services

Ziptek: Procedural Device, Resorbable, Tissue Fixation, Orthopedic – Sarasota, FL

Ziptek Introduces Breakthrough ZipE® Biolock™ Technology, Redefining Tissue Repair Worldwide

The Cs

PaceMate: Remote Pt. Monitoring, Cardiology – Bradenton, FL

Benjamin A. Steinberg, MD – CMO – Medical (Joining)

PaceMate Appoints Cardiac Electrophysiologist and NIH-Funded Researcher Benjamin A. Steinberg, MD, MHS, FACP, FACC, FHRS as Chief Medical Officer

Sovato Health: Remote Presence, Robotic Surgery – Goleta, CA

Brian Miller, PhD – CEO (Joining)

Sovato Appoints Brian Miller, PhD, as CEO to Scale New Era of Care Delivery

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

Richard Marshall, MD – CMO – Medical (Joining)

TriSalus Life Sciences Appoints Richard Marshall, M.D., as Chief Medical Officer

Cytovale: Diagnostic Test, Sepsis – San Francisco, CA

Eric Khairy – CMO – Marketing (Joining)

Cytovale Appoints Eric Khairy as Chief Marketing Officer

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

Liane Teplitsky – COO (Joining)

Pulse Biosciences Strengthens Executive Leadership Team

Board Members

Helio Genomics: AI, Diagnostic, Liquid Biopsy, Oncology – Irvine, CA

John Doyle – Board Member (Joining)

Helio Genomics Appoints Experienced Healthcare Technology Executive John Doyle to its Board of Directors

Supira Medical: Device, Cardiovascular, Percutaneous VAD – Los Gatos, CA

D. Keith Grossman – Board Member (Joining)

Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of Directors

CIRCA Scientific: Procedural Devices, Interventional Cardiology – Englewood, CO

Vafa Jamali – Board Member (Joining)

CIRCA Scientific Appoints MedTech Executive Vafa Jamali to Board of Directors

Funding

Latent: AI, Soft/SaaS, Precision Medicine – San Francisco, CA

Latent Raises $80M to Close the Gap Between Diagnosis and Treatment

Endovascular Engineering: Procedural Device, Vascular, Thrombectomy – Menlo Park, CA

E2 (Endovascular Engineering) Raises $80 Million Series C to Advance Next-Generation Thrombectomy Platform as Pulmonary Embolism Treatment Evolves

Route 92 Medical: Procedural Device, Neurovascular – San Mateo, CA

Route 92 Medical Announces $50 Million Growth Financing

Vertigenius: RPM, Therapy, Vertigo, Dizziness, Balance – Dublin, Ireland

Vertigenius Announces $3 Million Financing and Expands U.S. Availability of Its Vestibular Rehabilitation Platform

Click Therapeutics: Digital Therapeutics – New York, NY

Click Therapeutics and Boehringer Ingelheim Announce Series D Investment and Funding to Advance Commercialization of CT-155

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

Luminai Raises $38 million Series B to Scale Intelligence Across Health System Operations

Progentec Diagnostics: AI, Diagnostic Test, Autoimmune – Oklahoma City, OK

Progentec Diagnostics Advances Ability to Determine Lupus Risk with New Research and OCAST Grant

Surf Therapeutics: Equip., Ultrasound Neuromodulation, Inflammation – Austin, TX

Jetstream Venture Fund Secures Positions in Surf Therapeutics and Hill Research, Bolstering HealthTech and AI Portfolios

Regulatory

Approval
Neuropacs: AI, Soft/SaaS, Diagnostic, MRI Assist, Neurodegenerative, Parkinson’s – Gainesville, FL

FDA Grants De Novo Classification to neuropacs™, a First-in-Class AI-Based MRI Diagnostic Aid for Parkinsonian Syndromes

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

InVera Medical Receives FDA Clearance for InVera Infusion Device – a Novel Non-Thermal Catheter for Enhanced Infusion of Sclerosant for Chronic Venous Disease

IDE
TRiCares: Procedural Device, Cardiovascular Surgery, Heart Valve, Transcatheter – Paris, France

TRiCares Receives FDA Approval for TRICURE US IDE Pivotal Trial with the Topaz Tricuspid Valve Replacement System

Approval
Endospan: Implant, Stent Graft, Aortic Arch – Tel Aviv, Israel

Endospan Receives FDA Approval for the NEXUS® Aortic Arch Stent Graft System

Approval
Anumana: AI, Diagnostic, Cardiology – Cambridge, MA

Anumana Receives First and Only FDA Clearance for ECG-AI Cardiac Amyloidosis Algorithm Using a Standard 12-Lead ECG

Approval
Etiometry: Soft/SaaS, Clinical Decision Support – Boston, MA

Etiometry Receives a First-Ever FDA Clearance for Automating Hospital-Specific Cardiogenic Shock Classification and Tracking

IDE
Adagio Medical: Ablation, Ultra Low Temperature Cryoablation, Cardiology – Laguna Hills, CA

Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System

IDE
Supira Medical: Device, Cardiovascular, Percutaneous VAD – Los Gatos, CA

Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of Directors

Approval
BoxSPINE: Implant, Spinal – Plymouth, IN

BoxSPINE Receives FDA Clearance for Rodless Spinal Fixation System, Redefining a Decades-Old Surgical Approach

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

Hyperfine Receives CE and UKCA Marks for Next-Generation Swoop® System and Latest Advancement in Optive AI™ Software

Approval
Sibel Health: Wearable, Pt. Monitoring – Chicago, IL

Sibel Health Receives FDA-Clearance for ANNE® Maternal, a Comprehensive and Fully Wireless Maternal-Fetal Monitoring Platform

Submittal
Telix Pharmaceuticals: Diagnostic, Radiopharmaceutical, Cancer – Melbourne, Australia

FDA Accepts NDA for TLX101-Px (Pixclara®)

Product News

PlateletDiagnostics: Diagnostic Test, Platelet Function, Hematology – Watertown, MA

PlateletDiagnostics Announces Novel Immune-Based Platelet Function Assay to Monitor Antiplatelet Therapy

Reapplix: Wound Care – Birkerød, Denmark

Reapplix Awarded Technology Breakthrough Designation with Premier Inc. for Its 3C Patch® Wound Management System

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

GRAIL Announces Integration of the Galleri® Test into Epic Electronic Health Record Platform to Expand Access Nationwide

Hallmark Health Care Solutions : Soft/SaaS, Labor Mgt, Healthcare Systems – Charlestown, MA

Hallmark Health Care Solutions Enhances Flexible Workforce Solution with AI-Powered Intelligent Shift Collaboration to Reduce Frontline Leader Administrative Burden, Improve Staff Schedule Flexibility, and Manage Labor Expenses

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

InterVene Completes First 30 Cases Using the Recana® Thrombectomy Catheter System, Plans for Broader Commercial Launch

OpenEvidence: AI, Soft/SaaS, Clinical Information – Cambridge, MA

OpenEvidence Introduces Dotflows: AI-Native Customization For Every Clinician

DeepSight Technology: Diagnostic Imaging, Ultrasound for Ultrasound Guided Devices – Santa Clara, CA

DeepSight™ Technology Unveils its Comprehensive NeedleVue™ Platform at SIR 2026, Expanding the Future for Precision Ultrasound-Guided Interventions

Breakthrough Devices

CorTec: Implant, BCI, Stroke Recovery – Freiburg, Germany

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

Clinical Trials/Studies

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

New LockeT Data Accepted in Leading Electrophysiology Journal

PinkDx: Diagnostic Test, Gynecology, Cancer – Daly City, CA

PinkDx Publishes Groundbreaking Evidence in Endometrial Cancer Detection Using a Simple Vaginal Swab

Endovascular Engineering: Procedural Device, Vascular, Thrombectomy – Menlo Park, CA

Endovascular Engineering Announces Dual Late-Breaking Presentations at SIR and SCAI 2026 Highlighting Validation of Blood Return and Comprehensive ENGULF Study Results

ForSight Robotics: Robotics, Ophthalmic Surgery – Yokne’am Illit, Israel

ForSight Robotics Makes History with the World’s First-in-Human Fully Robot-Assisted Cataract Surgery

Okami Medical: Procedural Device, Peripheral Vascular Occlusion – Aliso Viejo, CA

Okami Medical Announces First Patient Enrolled in ALPHA Registry

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

Pulse Biosciences Enrolls First Patients in NANOPULSE-AF IDE Pivotal Clinical Study Evaluating nPulse™ Cardiac Catheter System for Atrial Fibrillation

KingstronBio: Implant, Heart Valves, Transcatheter – Shanghai, China

First Implant of KingstronBio’s ProStyle M® Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study

MiRus: Implant, Spine Surgery, Orthopedic Surgery, Interventional Cardiology – Marietta, GA

MiRus Begins Patient Enrollment in the STAR Randomized Trial of the Siegel™ Transcatheter Aortic Valve

Creyos: Soft/SaaS, Diagnostic, Neurology, Brain Health – Toronto, ON

Peer Reviewed Study Validates Creyos as a Faster, More Sensitive Approach to Dementia Detection in Primary Care

Medtrum: DME, Insulin Pump, Tubeless – Shanghai, China

Real-World Data from SFD 2026 Shows Clinical Benefits of Medtrum’s TouchCare® Nano Tubeless Insulin Pump

Alpheus Medical: Capital Equipment, Sonodynamic Therapy, Neuro Oncology – Chanhassen, MN

Alpheus Medical Initiates Phase 2b Trial of Investigational Therapy for Newly Diagnosed Glioblastoma

Scipher Medicine: AI, Precision Medicine, Immunology – Waltham, MA

Scipher Medicine Shares Published Data Further Validating RA Patient Outcome Improvement With PrismRA Testing

PharmaSens: Pump, Insulin Patch, Diabetes Mgt – Biel/Bienne, Switzerland

Data Published in Journal of Diabetes Science and Technology from First-in-Human Study Evaluating the Feasibility of Integrated Insulin Delivery and Glucose Monitoring Using an Insulin Patch Pump

SpeciCare: Cryopreservation, Biopsy – Gainesville, GA

New Peer-Reviewed Research Shows That Tissue Preservation Significantly Impacts the Future Utility of Precision Oncology

Partnerships

Aptar Digital Health: SaMD, Drug Delivery, Drug Dispensing – Congers, NY
Enable Injections: Drug Delivery Injector – Cincinnati, OH

Aptar Digital Health Partners with Enable Injections for enFuse® Companion Digital Solution

Welldoc: AI, Diagnostic, Digital Medicine, CCM – Columbia, MD
b.well Connected Health: AI, Soft/SaaS, Data Integration – Baltimore, MD

Welldoc Partners with b.well to Advance Interoperability and Seamless Patient Health Record Access

athenahealth: AI, Soft/SaaS, EMR, Pt. Engagement, Practice Mgt. – Boston, MA
rater8: Soft/SaaS, Healthcare Reputation Mgt. – Montvale, NJ

athenahealth Partners with rater8 to Add AI-Powered Reputation Management to Industry-leading AI-native athenaOne® Solution

Lightwheel: AI, Physical – Santa Clara, CA
PeritasAI: AI, Soft/SaaS, Perioperative Workflow – West Palm Beach, FL

Lightwheel and PeritasAI Announce Strategic Partnership to Bring Physical AI into Perioperative Workflows

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.