MedTech Startup Roundup – Vol.1 No.26

The news you need on MedTech startups

Dan’s Picks

Precise Bio: 3D Printing, Implant, Corneal, Ophthalmic Surgery – Greensboro, NC

Precise Bio Achieves World’s First 3D-Bio-Printed Corneal Implant

Hello!

Voio: AI, Soft/SaaS, Imaging Analysis – Berkeley, CA

Voio Emerges From Stealth to Build Frontier AI for Healthcare

Product Launches

Butterfly Network: AI, Imaging, Ultrasound, POCUS – Burlington, MA

Butterfly Network Launches Compass AI to Power the Next Generation of POCUS Program Management

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

Augurex Life Sciences Corp. Announces the Launch of the 14-3-3eta Test for Rheumatoid Arthritis Diagnosis and Monitoring with Sonic Reference Laboratory

Ozelle: Diagnostic, Capital Equip., Hematology, Biochemistry, Immunoassay – Frankfurt, Germany

Ozelle Launches Next-Generation AI + Complete Blood Morphology Solution at MEDICA 2025

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

Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants

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

TriSalus Life Sciences Launches TriNav® XP Infusion System to Expand Options for Pressure-Enabled Drug Delivery™

Atropos Health: AI, Clinical Decision Support – New York, NY

Atropos Health Launches the Atropos Evidence™ Agent with Microsoft Teams to Surface Personalized Evidence during Multidisciplinary Care Team Collaborations

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

Pearl Expands Pediatric Capabilities with Second Opinion® for Kids

PrognomiQ: Diagnostic, Test, Multi-Omics – San Mateo, CA

PrognomiQ Launches ProVue Lung, a Proteomics-Based Laboratory Developed Test to Aid in the Early Detection of Lung Cancer

Inovedis: Procedural Devices, Sports Medicine – Albstadt, Germany

Inovedis™ Continues to Simplify Arthroscopic Rotator Cuff Repair Surgery with the Release of SINEFIX™ TendoGrip

Avatar Medical: VR, 3D Rendering, Surgical Planning, Patient Education – Paris, France

Avatar Medical and Barco Evolve Exam Room Imaging with the Launch of Eonis Vision

TestDynamics : AI, Soft/SaaS, Imaging Analysis – Austin, TX

TestDynamics Introduces Amalgamated Intelligence™ – The First Holistic Intelligence Framework That Unifies All Medical Imaging AI Into One Cohesive System

Mach7 Technologies: Soft/SaaS, Imaging, Archival – Burlington, VT

Mach7 Technologies Launches New Flight Path for Medical Imaging – “from Archive to Architecture” at RSNA 2025

Product Launches

Volta Medical: AI, Diagnostic, Electrophysiology – Marseille, France
GE Healthcare: Capital Equipment – Chicago, IL

Volta Medical and GE HealthCare Announce Successful U.S. Launch of Joint AI-Driven Electrophysiology Solutions

M&A

Acquisition
Acera Surgical: Procedural Device, Soft Tissue Reinforcement – St. Louis, MO
Solventum: Multiple Product Lines – Maplewood, MN

Solventum Announces Agreement to Acquire Acera Surgical

The Cs

CoapTech: Procedural Device, Ultrasound-Guided, Gastrostomy – Baltimore, MD

Brad Kreger – CEO (Joining)
Howard Carolan – CEO & Co-Founder (Stepping Down)

CoapTech Announces Leadership Transition: Board Appoints Brad Kreger as Chief Executive Officer, Co‑Founder and CEO Howard Carolan Steps Down

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

Kevin Strange – CFO (Joining)

Cala Health Expands Leadership Team to Support Growing Adoption of the Cala TAPS Therapy for Tremor

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

Drew Hykes – President & CEO (Joining)

Okami Medical Announces $45 Million Financing and New CEO Appointment to Drive Next Phase of Growth

Ossium Health: Service, Bone Marrow Bank, Oncology – San Francisco, CA

Susannah Cantrell, PhD – CCO (Joining)

Susannah Cantrell Joins Ossium Health as Chief Commercial Officer

Channel Medsystems: Procedural Device, Endometrial Cryotherapy, Women’s Health – Berkeley, CA

Robert Brown – CFO (Joining)

Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer

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

Kathryn Weismantel – CMO – Marketing (Joining)
Christi Braun – CLO – Legal & CCO – Compliance (Joining)

IKS Health Appoints New Chief Marketing and Chief Legal and Compliance Officers

Board Members

MicroTransponder: Implant, Neuro, Post Stroke Recovery – Lakeway, TX

Dana G. Mead, Jr. – Chairman of the Board (Joining)
Cynthia Lucchese – Board Member (Joining)

MicroTransponder Appoints Dana G. Mead, Jr. as Chair of the Board and Adds Cynthia Lucchese as Independent Director

Distalmotion: Robotics, Surgical – Lausanne, Switzerland

Chas McKhann – Executive Chairman of the Board (Joining)

Distalmotion Raises $150 Million to Accelerate US Expansion of the DEXTER® Robotic Surgery System and Names Chas McKhann as Executive Chairman

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

Bill Hoffman – Chairman of the Board (Joining)

Okami Medical Announces $45 Million Financing and New CEO Appointment to Drive Next Phase of Growth

Fluid Biomed: Procedural Device, Aneurysm, Neurovascular – Calgary, AB

John Kilcoyne – Independent Chair of its Board of Directors (Joining)

Fluid Biomed Appoints Veteran MedTech Executive John Kilcoyne as Independent Board Chair

Funding

TearOptix : Contact Lens, Presbyopia Correction – Menlo Park, CA

TearOptix Secures Strategic Funding to Transform Presbyopia Treatment and Announces Creation of Scientific Advisory Board

VahatiCor: Procedural Device, Coronary Microvascular Dysfunction, Cardiology – Santa Clara, CA

VahatiCor Closes Oversubscribed Series B Financing to Accelerate A-FLUX® Development for Coronary Microvascular Dysfunction

VenstraMedical: Procedural Device, Transcatheter, Heart Failure – Newcastle, Australia

VenstraMedical Secures Investment From Highcroft Capital to Advance Next-generation Cardiac Support Device

Distalmotion: Robotics, Surgical – Lausanne, Switzerland

Distalmotion Raises $150 Million to Accelerate US Expansion of the DEXTER® Robotic Surgery System and Names Chas McKhann as Executive Chairman

Earflo: DME, Otitis Media Therapy, Pediatrics – Perth, Australia

Earflo Secures Investment from the Richard King Mellon Foundation to Transform Pediatric Ear Care

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

Hyperfine Awarded $3.7 Million Grant to Advance Global Brain Health

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

Okami Medical Announces $45 Million Financing and New CEO Appointment to Drive Next Phase of Growth

Ember: AI, Soft/SaaS, Reimbursement – San Francisco, CA

Nexus Venture Partners Leads $4.3M Seed Funding in Healthcare AI Startup Ember

WellBeam: Soft/SaaS, Connected Care – Redwood City, CA

WellBeam closes $10 Million Series A to Transform Clinical Interoperability and Care Coordination between Acute and Post-Acute Providers

Annie Labs: AI, Soft/SaaS, Front Desk, Dental – Salt Lake City, UT

Annie Announces $4M Seed Round Led by CV

GramEye : AI, Robotic, Capital Equip, Diagnostic, Antimicrobial Resistance – Ibaraki, Japan

GramEye Raises 570 Million Yen in Series B Funding to Accelerate Global Expansion Toward Solving the AMR Crisis with AI

Regulatory

Approval
Arctx Medical : Capital Equipment, Cool Therapy, Pancreatitis – Raleigh, NC

Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter™ Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

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

Cardiovalve Submits CE File for Approval Following Successful TARGET Study Completion

Approval
QuantalX Neuroscience: Diagnostic, Imaging, Neurodiagnostic – Kfar Saba, Israel

QuantalX Receives FDA De Novo Clearance for Delphi-MD, Establishing a New Modality of Brain Function Assessment

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

Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology

Approval
Piccolo Medical: Capital Equip, Diagnostic, Vascular Access – San Francisco, CA

Piccolo Medical® Receives FDA Clearance to Expand ECGuide™ Technology Use to Pediatric and Neonatal Patients

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

Bot Image, Inc. Earns UKCA Certification for ProstatID® AI Prostate MRI Software Under EU MDR 2002 No. 618

Approval
Levita Magnetics: Capital Equipment, Minimally Invasive Surgery, Abdominal – Mountain View, CA

Levita’s Magnetic Surgical System Achieves FDA Clearance for Pediatric Use; Cleveland Clinic Children’s Performs First Case with MARS System

Approval
RapidAI: AI, Neurovascular, Aneurysm Identification – Menlo Park, CA

RapidAI Earns FDA Clearance for Rapid Aortic, Bringing AI-Driven Aortic Measurements and Surveillance to Care Teams

IDE
Paradromics: Implant, BCI, Neurosurgery – Austin, TX

Paradromics Receives FDA Approval for the Connect-One Clinical Study with the Connexus® Brain-Computer Interface

Approval
Overture Life : System, Automated Egg Freezing, IVF – Madrid, Spain

Overture Life Receives CE Mark Approval to Commercialize Fertility Automation in Europe

Approval
Transmural Systems : Procedural Device, Structural Heart, Cardiac Surgery – Andover, MA

Transmural Systems Receives FDA 510(k) Clearance for Telltale

NSE
HeartBeam: DME, ECG – Santa Clara, CA

HeartBeam Stock Slumps After FDA Refuses Clearance For ECG Software

Product News

Caranx Medical: AI, Soft/SaaS, Interventional Cardiology, TAVI – Paris, France

Caranx Medical Announces First Clinical Use of the TAVIPILOT Soft, Cleared by FDA for Commercial in July: the World First AI Software for Real-Time Intra-Operative Guidance of Transcatheter Heart Valve Implantation

Alafair Biosciences: Procedural Device, Orthopedic Surgery, Tendon Repair, Nerve Repair – Austin, TX

Alafair Biosciences Announces First Clinical Use of VersaCoat™ Flowable Hydrogel in Foot & Ankle and Hand & Wrist Procedures

NewVue.ai: AI, Soft/SaaS, Radiology Workflow – Tampa, FL

NewVue Debuts Next Evolution of Radiologist Cockpit, Redefining Workflow Orchestration Ahead of RSNA 2025

Precise Bio: 3D Printing, Implant, Corneal, Ophthalmic Surgery – Greensboro, NC

Precise Bio Achieves World’s First 3D-Bio-Printed Corneal Implant

Viseon: Imaging, Guided, Neurosurgery – Irvine, CA

Viseon Announces First Human Use of Hubble™ EXCITE

Breakthrough Devices

Nanopath: Diagnostic, Molecular, POC, UTI, Urology – Cambridge, MA

Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

Reimbursement

Naveris: Diagnostic, Liquid Biopsy, Oncology, Precision Medicine – Waltham, MA

Naveris Announces Expanded Medicare Coverage for the NavDx® Test in Identification of Molecular Residual Disease of Anal Squamous Cell Carcinoma

Vesiflo: DME, Urinary Incontinence – Redmond, WA

CMS Establishes National Pricing for Vesiflo’s inFlow™ Voiding Prosthesis

Clinical Trials/Studies

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

KORU Medical Systems to Present Promising Results on the Use of the FreedomEDGE® Syringe Infusion System in Infusion Centers at ESID/EHA/SIOPE Focused Symposium 2025

Riverain Technologies: Soft/SaaS, Image Analysis, Cardiothoracic – Miamisburg, OH

Study Shows ClearRead™ CT CAC for Incidental Coronary Artery Calcification Highly Effective on Ungated CT Exams

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

Anteris Technologies Presents Data from 100 DurAVR® THV Patients at PCR London Valves

Autonomix Medical: Procedural Device, Nerve Ablation, Guided, Transvascular – The Woodlands, TX

Autonomix Medical, Inc. Reports Positive Subgroup Results Demonstrating Sustained Improvements in Quality of Life from Post Hoc Analysis of Pancreatic Cancer PoC Study

inTRAvent Medical: Capital Equip., Imaging, Ultrasound-Guided, Neuronavigation – Hershey, PA

Landmark Bench Study Shows Dramatic Improvement in Ventricular Catheter Placement Accuracy with inTRAvent Medical’s First in Class, FDA-Cleared SOLOPASS 2.0 Ultrasound-Guided Neuronavigation System

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

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

Archeon Medical: Ventilator, EMS – Besançon, France

Archeon Medical: first responder study shows novel ventilation device triples survival rates without brain damage in cardiac arrest care – US clinical trials to follow

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

Micro-ultrasound Proven Non-Inferior to MRI for Prostate Cancer Diagnosis in OPTIMUM Randomized Trial

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

ENDRA Feasibility Study Demonstrates TAEUS® Accurately Quantifies Liver Fat Fraction, a Key MASLD/MASH Biomarker

Paradromics: Implant, BCI, Neurosurgery – Austin, TX

Paradromics Receives FDA Approval for the Connect-One Clinical Study with the Connexus® Brain-Computer Interface

Allurion Technologies: Procedural Device, Bariatrics – Natick, MA

New Peer-Reviewed Publication Demonstrates Superior Weight Loss and Improved Body Composition with the Allurion Smart Capsule Combined with Lifestyle Intervention Compared to Lifestyle Intervention Alone

Imperative Care: Procedural Device, Robotics, Thrombectomy, Neurovascular, Vascular – Campbell, CA

Imperative Care Presents Positive Real-World Data from Ischemic Stroke Patients Treated with ADAPT 2.0 Using the Zoom Stroke System

iRhythm Technologies: AI, Telehealth, DME, ECG, Cardiology – San Francisco, CA

New Data at the Asia Pacific Heart Rhythm Society (APHRS) 2025 Highlight the Performance of iRhythm’s Zio Long-Term Continuous Monitoring in an Asian Population

Clinical Trials/Studies

CryoTherapeutics: Procedural Device, Cryotherapy, Coronary – Loncin, Belgium
SpectraWAVE: AI, Imaging, Cardiovascular – Bedford, MA

CryoTherapeutics partners with SpectraWAVE and CRF to Launch ICECAP: A First-of-its-Kind Clinical Study Targeting Non-Obstructive High-Risk Coronary Plaques with Cryotherapy and Advanced Intravascular Imaging

Partnerships

Artella Solutions: Remote Pt. Monitoring, Cardiology, Sleep – Houston, TX
PranaQ: Diagnostic, Remote Pt. Monitoring, Sleep, – New York, NY

Artella Solutions Expands Diagnostic Platform into Sleep Medicine Through Strategic Partnership with PranaQ

Therapixel: AI, Image Analysis, Radiology, Breast Cancer – Nice, France
CureMetrix: AI, Image Analysis, Radiology, Breast Cancer – San Diego, CA

CureMetrix and Therapixel Partner to Integrate cmAngio and MammoScreen

Patents

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

Second Heart Assist Announces New U.S. Patent and Declares the Dawn of Intelligent Circulatory Support

This & That

Freenome: Diagnostic, Cancer Screening – South San Francisco, CA
Roche: Diagnostics, Pharmaceuticals – Basel, Switzerland

Freenome Announces Exclusive Agreement with Roche to Expand Technology Collaboration and Develop and Commercialize Cancer Screening Tests Outside the U.S.

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.