MedTech Startup Roundup – Vol.1 No.21

Nalu Medical: Neurostimulation, Pain, Peripheral – Carlsbad, CA
Boston Scientific : Procedural Device, Implant, Capital Equip – Marlborough, MA

Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc.

IPOs

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

Hyperfine Announces Proposed Public Offering

The Cs

ImpriMed: Diagnostic, Precision Medicine, Oncology – Palo Alto, CA

Valerie Goodwin-Adams – CCO (Joining)

ImpriMed Accelerates Growth With Strategic Leadership Hire and Major Operational Milestones

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

Mimi Lee, MD, PhD – CPMO – Precision Medicine (Joining)

GeneDx Appoints Dr. Mimi Lee as Chief Precision Medicine Officer

Nymbl Systems: Soft/SaaS, Practice Mgt., O&P, CRT, and HME – Columbus, OH

Chris Keefe – CPO – Product (Joining)

Nymbl Systems Names Chris Keefe Chief Product Officer to Lead Product Strategy and Innovation

Board Members

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

Tim Sullivan – Board Member (Joining)

Sibel Health Secures Additional Series C Extension Funding to $39 million from Key Strategic Investors and Announces New Board of Director Appointments

Funding

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

ENDRA Life Sciences Announces At-Market Private Placement of Up to $14.4 Million to Launch Digital Asset Treasury Strategy Managed by Leading Crypto Asset Manager Arca

OutcomesAI : AI, Soft/SaaS, Voice Agents, Nursing Care – Boston, MA

OutcomesAI Secures $10M Seed Financing Led by Santé Ventures to Scale AI-Enabled Nursing Care

Smartlens: Device, Glaucoma Mgt, Ophthalmology – Mountain View, CA

Smartlens, Inc. Secures $5.2 Million Bridge Round to Advance FDA Clearance Process and Prepare for Commercial Launch of miLens

Medmo: AI, Care Coordination, Imaging – New York, NY

Medmo Raises $15 Million Series A Funding Round

MD Integrations: Telehealth – New York, NY

MD INTEGRATIONS RAISES $77 MILLION FROM UPDATA PARTNERS AND DENALI GROWTH PARTNERS TO ACCELERATE INNOVATION IN TELEHEALTH; APPOINTS PRESIDENT & COO

Sibel Health: Wearables – Chicago, IL

Sibel Health Secures Additional Series C Extension Funding to $39 million from Key Strategic Investors and Announces New Board of Director Appointments

iSono Health: AI, Imaging, Ultrasound, Breast – South San Francisco, CA

JSK Investments backs US startup iSono Health to bring smart breast screening to women worldwide

ABK Biomedical: Procedural Device, Neurosurgery, Brain Cancer – Halifax, NS

ABK Biomedical Raises US$35M in Series D Financing

Altitude: AI, Soft/SaaS, Clinical Decision Support – New York, NY

Excited to be a first investor in Altitude

Adagio Medical: Cryoablation, Cardiology, Ventricular Tachycardia – Laguna Hills, CA

Adagio Medical Announces Pricing of up to $50 Million Private Placement of Securities

Vega Health: AI, Soft/SaaS – Durham, NC

Vega Health Launches to Accelerate Adoption of Validated AI Solutions at Health Systems Nationwide

HistoSonics: Capital Equip, Histotripsy, Oncology, Hepatic – Minneapolis, MN

HistoSonics Announces Oversubscribed $250 Million Growth Financing

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

ATDev Secures $3 Million Seed Investment to Scale Assistive Mobility Ecosystem

Sage Care: AI, Soft/SaaS, Care Navigation – Palo Alto, CA

Sage Care Emerges From Stealth with $20M in Funding for an AI-Powered Care Navigation System

Regulatory

Approval
Zeta Surgical: AI, Navigation System, Neurosurgery – Boston, MA

Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance

Approval
Surgical Theater: XR, Surgical Imaging, Neurosurgery, Spine Surgery – Cleveland, OH

Next-Generation AI-Driven SyncAR® Spine Receives FDA Clearance for Spine Surgery

Approval
Nurea : AI, Soft/SaaS, Diagnostic, Decision Making, Aortic Aneurysm – Bordeaux, France

Nurea Receives FDA Clearance for PRAEVAorta®2, Bringing Advanced Aortic Aneurysm Management to the U.S. Market

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

Avisi Technologies Receives FDA Approval to Study Novel Approach to Glaucoma Treatment

Approval
Centinel Spine: Implant, Spine, Spine Surgery – West Chester, PA

Centinel Spine® Receives Two-Level FDA Approval for prodisc® C Vivo and prodisc® C SK Match-the-Disc™ Cervical Total Disc Replacement Devices

Approval
Simergent: Dialysis, Peritoneal, Home Care – Oklahoma City, OK

Simergent Announces FDA Clearance of the Archimedes™ Home Dialysis System

Approval
OcuSciences: Imaging, Ophthalmic – Ann Arbor, MI

OcuSciences Secures EU CE Clearance and Expands European Presence with OcuMet Beacon Instruments

IDE
Micro Interventional Devices: Implant, TAVR, Interventional Cardiology – Newtown, PA

Micro Interventional Devices Receives FDA Approval of the STTAR-US IDE Pivotal Trial for its MIA™-T Percutaneous Tricuspid Annuloplasty System

Approval
BellaMia Technologies: Device, Laser, Aesthetic – San Antonio, TX

FDA Clearance for The Botticelli: The World’s First Complete Solution for Skin Rejuvenation

Approval
Deep Breathe: AI, Imaging, Ultrasound, Lung, Pulmonology – London, ON

Deep Breathe Secures FDA Clearance for Groundbreaking AI Lung Ultrasound Diagnostic

Approval
Vara: AI, Soft/SaaS, Breast Imaging – Berlin, Germany

Vara earns CE mark as the only AI authorized for an independent second read in mammography, and expands in Europe

Product News

Proscia: AI, Diagnostic, Precision Medicine, Pathology, Dermatopathology – Philadelphia, PA

Proscia to Broaden Pathology AI Capabilities with Biomarker Detection for Skin Tissue

Welldoc: AI, Diagnostic, Digital Medicine, CCM – Columbia, MD

Welldoc Expands AI-Powered Cardiometabolic Platform to Include Chronic Kidney Disease and MASH Support

Artisight: AI, Soft/SaaS, Ambient Listening – Chicago, IL

Artisight Introduces Smart Hospital Rooms with Ambient Documentation and Touchless Authentication

GenHealth.ai: AI, Soft/SaaS, Intake, Prior Authorization, DME Resupplies – Vienna, VA

GenHealth.ai and Guidehealth Achieve Up to 60% Reduction in Utilization Management Workload Through AI-Native Platform

Breakthrough Devices

Scanogen: Diagnostic, Rapid, Infectious Disease, Sepsis – Baltimore, MD

Scanogen Receives FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay

CAPS Medical: Procedural Device, Ablation, Bladder Cancer, Oncology, Urology – Santa Monica, CA and Netanya, Israel

CAPS Medical’s PlasmaSure™ Receives FDA Breakthrough Device Designation

Reimbursement

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

EBR Secures NTAP and TPT Reimbursement for the WiSE System, effective October 1, 2025

Pleural Dynamics: Implant, Automatic Continuous Effusion Shunt System, Thoracic Surgery – Minneapolis, MN

CMS Grants HCPCS Code and NTAP Classification for Pleural Dynamics’ Novel ACES Automatic Continuous Effusion Shunt

Levee Medical: Scaffold, Urology Surgery, Post-Prostatectomy – Durham, NC

American Medical Association Grants Levee Medical Category III CPT Code for Placement of Voro® Urologic Scaffold

Clinical Trials/Studies

NEXTBIOMEDICAL: Injectable, Procedural, Chronic Pain, Knee, Hemostasis – Incheon, South Korea

NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain

Establishment Labs: Implants, Breast, Plastic Surgery, Breast Surgery – Alajuela, Costa Rica

Establishment Labs Notes Publication of Mia Femtech 3-Year Prospective Study Results in Aesthetic Surgery Journal

Conformal Medical: Procedural Device, Left Atrial Appendage, Cardiology – Nashua, NH

Conformal Medical Announces First Patient Enrollment in the E.U. for CONFORM Pivotal Trial with The CLAAS® AcuFORM™ LAAO Device

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

Avisi Technologies Receives FDA Approval to Study Novel Approach to Glaucoma Treatment

Arima Genomics: Diagnostic, Precision Med, Genomics, Oncology – Carlsbad, CA

Arima Genomics Announces New Study Showing Aventa™ Lymphoma Test Resolves Diagnostic Ambiguity and Guides Care in B-Cell Lymphoma Cases

Sonex Health: Procedural Device, Minimally Invasive, Ultrasound-Guided, Orthopedic Surgery – Eagan, MN

SONEX HEALTH ACHIEVES ENROLLMENT TARGET IN LARGEST-EVER MULTI-ARM U.S. STUDY ON PATIENTS TREATED WITH CARPAL TUNNEL RELEASE

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

Spark Biomedical Publishes Peer-Reviewed Trial Showing Wearable Device Reduces Heavy Menstrual Bleeding

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

MMI Enrolls First Patient in Landmark U.S. Clinical Study Advancing Robotic Microsurgery

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

Anteris Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

Portal Instruments: Drug Delivery, Needle-Free – Cambridge, MA

Portal and Regeneron Publish PRIME® Needle-Free Innovation Study, Informing Next-Generation Platform Development

BRAINBox Solutions: AI, Diagnostic, Brain Injury, Neurology – Richmond, VA

BRAINBox Solutions Announces Publication in JAMA Network OPEN of Major Analysis of Initial HeadSmart II Trial Concussion Patients

Episurf Medical: Implant, Orthopedic Surgery – Stockholm, Sweden

Scientific article on Episealer® Knee with up to 10 years’ follow-up published

Partnerships

Synaptive Medical : Imaging, Surgical MRI, Navigation, Neurosurgery, Surgical Planning – Toronto, ON
Centile Bioscience: AI, Diagnostic, Brain – London, UK

Synaptive Medical and Centile Bio Partner to Advance AI-Enhanced Surgical Planning

OpenEvidence: AI, Soft/SaaS, Clinical Information – Cambridge, MA
Veeva Systems: Soft/SaaS, Data, Consulting – Pleasanton, CA

OpenEvidence and Veeva Announce Open Vista Partnership

Amalgam Rx: AI, SaMD, HRE – Wilmington, DE
Biolinq: Biowearables, Diabetes – San Diego, CA

Amalgam Rx Partners with Biolinq — Lighting Pathways to Better Health

Patents

XRHealth: XR, Physical Therapy, Cognitive Therapy – Needham, MA

XRHealth Awarded U.S. Patent for Pioneering XR System Measuring Upper-Limb Impairments

bioAffinity Technologies: Diagnostic Test, Liquid Biopsy, Oncology, Lung Cancer – San Antonio, TX

bioAffinity Technologies Announces Notification of Allowance for U.S. Patent Application for Its Diagnostic Algorithm and Test Method for Lung Cancer

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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