MedTech Startup Roundup – Vol.1 No.24

Acquisition
TECHFIT Digital Surgery: 3D Printing, Soft/SaaS, Surgical Planning, CMF Surgery – Daytona Beach, FL
Acumed: Implant, Orthopedic Surgery, CMF Surgery – Hillsboro, OR

Acumed Acquires Assets of TECHFIT Digital Surgery, Expanding Patient-Tailored Solutions in the Craniomaxillofacial Space and Beyond

Acquisition
EyePACS: Soft/SaaS, Teleophthalmology Network – Santa Cruz, CA
Optain Health: AI, Remote Diagnostic, Ophthalmology – New York, NY

Optain Health Acquires EyePACS to Expand Access to Next-Generation Retinal Imaging for Primary Care and Advance Oculomics

IPOs

BillionToOne: Diagnostic, Liquid Biopsy, Oncology, Obstetric – Menlo Park. CA

BillionToOne Announces Pricing of Upsized Initial Public Offering

The Cs

InspireMD : Procedural Device, Vascular Surgery, Neurosurgery, Carotid Stent – Miami, FL

Peter A. Soukas, MD – CMO – Medical (Joining)

InspireMD Names Peter A. Soukas, M.D., as Chief Medical Officer

BrainScope: AI, Diagnostic, Neurology – Rockville, MD

Matt Adams – CEO (Joining)

BrainScope Names Matt Adams as Chief Executive Officer

Curonix: Wearable, PNS, Pain – Pompano Beach, FL

Russell Fleeger – CFO (Joining)

Curonix Strengthens Executive Leadership with Appointment of Leading Medical Device Executive Russell Fleeger as Chief Financial Officer to Drive Next Stage of Growth

Regard: AI, Soft/SaaS, Proactive Pt. Data Collection – Los Angeles, CA and New York, NY

David Kirk, MD – CMO – Medical (Joining)

Regard Appoints Dr. David Kirk as Company’s First Chief Medical Officer Amid Period of Rapid Growth

THINK Surgical: Robotic, Capital Equip, Orthopedic Surgery – Fremont, CA

Josh DeRienzis – CLO – Legal (Joining)

THINK Surgical appoints Josh DeRienzis as Chief Legal Officer

Amber Implants: Implants, Spine Surgery – The Hague, Netherlands

Vincent Gardès – CEO (Joining)

Amber Implants Appoints Vincent Gardès as Chief Executive Officer to Drive Commercial Launch of VCFix® Spinal System

Board Members

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

Didric Cederholm – Board Member (Joining)

Median Technologies Appoints Didric Cederholm to Its Board of Directors

BrainScope: AI, Diagnostic, Neurology – Rockville, MD

Matt Adams – Board Member (Joining)

BrainScope Names Matt Adams as Chief Executive Officer

Funding

Hippocratic AI: AI, Soft/SaaS, Generative Agents, Pt. Safety – Palo Alto, CA

Hippocratic AI Raises $126 Million in Series C at $3.5 Billion Valuation Led by Avenir Growth to Expand Clinically Safe Generative AI Agents Across Healthcare

Popai Health: AI, Soft/SaaS, Pt. Care via Pt. Voice Communication – San Francisco, CA & Tel Aviv, Israel

Popai Health Raises $11M to Transform Care Coordination with Voice AI

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

Sovato Closes Series B to Advance the World’s First and Only Remote Robotic Surgery & Procedure Platform

FIZE Medical: AI, Capital Equip, Fluid Mgt – Modi’in, Israel

FIZE Medical Secures Investment and Expands Israeli Distribution Through Eldan, a Neopharm Group Company

Guardant Health: Diagnostic Test, Liquid Biopsy, Oncology – Palo Alto, CA

Guardant Health Announces Proposed Public Offering of Common Stock

Guardant Health: Diagnostic Test, Liquid Biopsy, Oncology – Palo Alto, CA

Guardant Health Announces Proposed $300.0 Million Offering of Convertible Senior Notes Due 2033

HoloMD: AI, Remote Monitoring, Mental Health – Rockville, MD

HoloMD Closes $1.6M Seed Round First Tranche; Announces Investor Briefing on November 11

Coherence Neuro: BCI, Implant, Stimulation, Cancer – San Francisco, CA

Startup in spotlight: Coherence Neuro raises $10M to launch closed-loop neuro system for cancer treatment

Tala Health: AI, Soft/SaaS, AI Agents, Remote Medicine – San Francisco, CA

Titan Holdings, Building AI Businesses Across Key Industries, Unveils Newest Venture: Tala Health

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

EIB finances with €20 million Overture Life to invest in automatization of assisted reproductive processes and product expansion

LambdaVision: Implant, Ophthalmic Surgery, Retina Replacement – Farmington, CT

LambdaVision Raises $7M Seed Round to Revolutionize Blindness Treatment Using Space-Based Manufacturing

Precision Neuroscience: BCI, Electrode Interface – New York, NY

Precision Neuroscience and SCI Ventures Partner to Bring Brain–Computer Interfaces to People Living with Paralysis

Synchron: BCI, Implant – Brooklyn, NY

Synchron Raises $200 Million Series D to Advance Brain-Computer Interface Technology

Elephas : Predictive Medicine, Diagnostic, Oncology – Madison, WI

ELEPHAS BIOSCIENCES RAISES $40M TO ACCELERATE COMMERCIALIZATION OF ITS LIVE TUMOR PROFILING PLATFORM

SiteLabs: Diagnostic, POC, Pharmacy – Anderson, SC

SiteLabs Raises $2M in Seed Funding

Regulatory

Approval
Pulsenmore : Ultrasound, Remote Medicine, Obstetrics – Omer, Israel

Pulsenmore Receives FDA De Novo Marketing Authorization for Home-Use Prenatal Ultrasound, Pioneering a New Era of Prenatal Care in the U.S.

Submittal
Tulyp Medical : Procedural Device, Vascular – Paris, France

Tulyp Medical Emerges From Sofinnova’s Medtech Accelerator and Announces FDA Submission Following Initial First-in-Human Use

IDE
MMI – Medical Microinstrument: Robotics, Microsurgery – Pisa, Italy

UPDATE – MMI Receives IDE Approval from FDA for First Robotic Microsurgical Study in Alzheimer’s Patients

Approval
UroViu : Procedural Device, Disposable, Urology – Los Altos, CA

UroViu Receives CE Certification of Its Wi-Fi Enabled Cystoscope and Hysteroscope Product Portfolio

Approval
Nitinotes: Procedural Device, GI Surgery, Automated Suturing Platform – Caesarea, Israel

Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty

Product News

Elation Health: Soft/SaaS, EHR, Practice Mgt, Primary Care – San Francisco, CA

Elation Health Expands Pediatrics Capabilities

Imricor Medical Systems: Imaging, Guidance, VT Ablation, Electro-Physiology – Minneapolis, MN

First in Human Ischemic VT Ablation Successfully Performed in iCMR

Reimbursement

Sensus Healthcare: Capital Equip, Superficial Radiotherapy, Skin Cancer, Dermatology – Boca Raton, FL

CMS Establishes Coding Validating Sensus SRT for Treating Non-Melanoma Skin Cancer

Clinical Trials/Studies

Avisi Technologies: Procedural Device, Ophthalmic Surgery, Glaucoma – Redwood City, CA

Avisi Technologies Announces Positive Twelve-Month Clinical Data of VisiPlate® Aqueous Shunt at AAO 2025

IceCure Medical: Procedural Device, Minimally Invasive, Cryoablation, Breast Cancer – Caesarea, Israel

IceCure’s Cryoablation System Combined with Radiation Therapy Successfully Treats Non-Small Cell Lung Cancer (NSCLC) with 92% Disease-Specific 5-year Survival

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

E2 (Endovascular Engineering, Inc) Presents ENGULF Pivotal Study as a Late-Breaking Clinical Trial at the VIVA Conference

IR-MED: AI, Clinical Decision Support, POC, Wound Care – Rosh Pinna, Israel

IR-MED Ltd. Announces Launch of First-in-Human Clinical Trial of Its DiaSafe(TM) Device for Diabetic Foot Ulcer (DFU) Assessment

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

Latest Data from Landmark STORM-PE Randomized Controlled Trial Demonstrate that CAVT with Anticoagulation Significantly Improves Functional Outcomes for Patients with Pulmonary Embolism

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

FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

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

New Data Show Viz.ai’s AI-Enabled ECG Screening Increases Detection and Accelerates Diagnosis of Hypertrophic Cardiomyopathy

RevBio: Procedural Device, Osteoconductive Bone Adhesive, Oral & Maxillofacial Surgery, Orthopedic Surgery – Lowell, MA

RevBio® Receives First FDA Approval for a “Bone Glue” to Treat Extremity Fractures in a Clinical Trial

REVEAL GENOMICS: Diagnostic, Biomarker, Oncology, Breast Cancer – Barcelona, Spain

Nature Communications Study Supports HER2DX as a Genomic Tool for Tailored Therapy in Older Individuals With HER2+ Breast Cancer

Amplitude Vascular Systems: Procedural Device, IVL, Peripheral Vascular – Waltham, MA

AVS Announces Positive Safety and Effectiveness Data in First 95 Patients Treated in Pulse IVL IDE Study

Contego Medical: Procedural Device, Embolic Protection – Raleigh, NC

Contego Medical Announces Unprecedented 30-day Outcomes From The PERFORMANCE III TCAR-IEP Study

SPR Therapeutics: Procedural Device, Peripheral Nerve Stimulation, Neurology – Cleveland, OH

RESET™ Clinical Trial Demonstrates Superior Pain Relief with SPRINT® PNS Compared to Standard Interventional Management for Chronic Low Back Pain

Healionics: Implant, Vascular Graft, Vascular Surgery – Seattle, WA

24-Month Clinical results for Healionics’ STARgraft featured at CiDA conference

Lungpacer Medical: Neurostimulation of Diaphragm, Breathing – Vancouver, BC

Lungpacer Medical Announces First Enrollments in STARI Trial of Next-Generation Neurostimulation Therapy

SIS Medical: Procedural Device, Angioplasty, Interventional Cardiology, Interventional Radiology – Frauenfeld, Switzerland

SIS Medical AG Welcomes the Results of the VICTORY Trial Demonstrating Non-inferiority of OPN NC to Intravascular Lithotrispy (IVL) for Lesion Preparation and Stent Expansion in Severely Calcified Lesions

4WEB Medical: Implant, Orthopedic – Frisco, TX

4WEB Medical Ushers in the Era of Therapeutic Implant Technology

DermaSensor: AI, Diagnostic, Skin Cancer, Dermatology – Miami, FL

Two New Studies Show DermaSensor™ Devices’ Consistent Performance and Improvements to Physicians’ Melanoma Detection

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

Raydiant Oximetry Launches IDE Pilot Study at LSU Health Shreveport to Advance Fetal Monitoring Technology

MMI – Medical Microinstrument: Robotics, Microsurgery – Pisa, Italy

UPDATE – MMI Receives IDE Approval from FDA for First Robotic Microsurgical Study in Alzheimer’s Patients

Illuminare Biotechnologies: Image Enhancement, Surgical, Nerve Illumination – Brooklyn, NY

Illuminare Biotechnologies’ Rizedisben Demonstrates Safety and Efficacy in Phase 1 Clinical Trial Results

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

Agitated Solutions Enrolls First Patient in Phase 3 ‘ENHANCE’ Trial of Novel Contrast Agent for Cardiac Bubble Studies

PhotoPharmics: Phototherapy, Parkinson’s, Neurology – Lehi, UT

Woori IO: Diagnostic, Non-Invasive Biosensor, Glucose, Endocrinology – Jeonju, South Korea

OSR Holdings Announces Woori IO’s Noninvasive Glucose Monitor Demonstrates High Accuracy and Precision in Company-Sponsored Pilot Study

EBR Systems: Cardiac Pacing, Wireless, Cardiology – Sunnyvale, CA

EBR Systems Achieves First Enrollments in the WiSE-UP Study for Heart Failure Patients

Enspectra Health: Imaging, Diagnostic, Skin Cancer – Mountain View, CA

Study Published in JAMA Dermatology Validates Enspectra Health’s Cross-Modal Imaging System for Noninvasive Visualization of Histologic Skin Features

Partnerships

AIxMed: AI, Diagnostic, Digital Cytology – Santa Clara, CA
PathNet: Diagnostic, Service, Digital Pathology – Little Rock, AR

AIxMed and PathNet Partnership: Advancing Digital Pathology with AI-Powered Urine Cytology

Aceso Interactive: Soft/SaaS, Pt. Engagement, Digital Communication – Wilbraham, MA
Samsung: Electronics – Suwon. South Korea

Aceso Interactive and Samsung Partner to Advance Patient Engagement and Digital Signage in Healthcare

This & That

Assistive Technology Development (ATDev): Robotic, Physical Rehab, Mobility – Loveland, CO

ATDev Joins $41 Million ARPA-H Initiative to Build the Future of Robotic Mobility and Independence

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!

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