MedTech Startup Roundup – Vol.1 No.6

As a medical recruiting, we conduct thorough research on startups and early-stage companies because these are the companies, people, and products that drive innovation and create opportunities. This is the type of information we have used to place with over 550 medical sales organizations. The research has always been kept in-house, but now we are providing you with the same robust information – at no cost to you. Want to stay ahead of the curve and discover what’s new and next? Register today for the MedTech Startup Roundup. Follow the links to discuss a potential search or submit your resume

M&A

Fifth Eye: Soft/SaaS, Predictive Analytics, Cardiology – Ann Arbor, MI
AirStrip Technologies: Soft/SaaS, Clinical Decision Support – San Antonio, TX

AirStrip Acquires Fifth Eye to Advance Predictive Clinical Surveillance

The Cs

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

Gordon Downie, MD, PhD, – CMO – Medical (Joining)

BioAffinity Technologies Appoints Dr. Gordon Downie, MD, PhD, as Chief Medical Officer

Elemeno Health: Soft/SaaS, Education, Training – Oakland, CA

Tim Coulter – CEO (Joining)

Elemeno Health Taps Tim Coulter as CEO to Lead Next Phase of Growth

Freenome: Diagnostic, Cancer Screening – South San Francisco, CA

Linh H. Le – CFO (Joining)

Freenome Appoints Linh H. Le as Chief Financial Officer

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

Carolyn Walsh – CEO (Joining)

DermaSensor Welcomes Carolyn Walsh as Chief Commercial Officer and Announces Commercial Advisory Board

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

Joe Hayon – President (Resigning)

Inspira Technologies Aligns Executive Team Amid Corporate Structuring Initiatives

Life365: Soft/SaaS, Remote Pt. Monitoring – Scottsdale, AZ

Jay Roberts – CDO – Development (Joining)

Life365 Appoints Jay Roberts As Chief Development Officer

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

David B. Patience – CFO (Joining)
James E. Young – CFO (Resigning)

TriSalus Life Sciences Announces Chief Financial Officer Transition With Appointment of David B. Patience

Spectral AI: AI, Wound Care – Dallas, TX

Stanley Micek – COO (Promotion)

Spectral AI Announces Appointment of Stanley Micek as Chief Operating Officer

Rad AI: AI, Soft/Saas, Radiology Workflows – San Francisco, CA

Demetri Giannikopoulos – CGO – Growth (Joining)

Rad AI Names Demetri Giannikopoulos as Chief Growth Officer to Accelerate AI-Driven Radiology Healthcare Growth

Board Members

Brainomix: AI, Imaging, Neurovascular – Oxford, UK

Khush F. Mehta – Chairman of the Board (Joining)

Brainomix Appoints Khush F. Mehta as Chair to Support Global Expansion and Commercial Growth

Exo: AI, Diagnostic Ultrasound, Cardiology – Santa Clara, CA

Omar Ishrak – Board Member (Joining)

Exo® Announces Samsung Medison Strategic Collaboration and Welcomes Omar Ishrak to its Board

Imperative Care: Device, Neurovascular, Thrombectomy – Campbell, CA

Tyler Binney – Board Member (Joining)

Imperative Care Announces Appointment of Tyler Binney to Board of Directors

Funding

Biostate AI: Diagnostic, Soft/SaaS, Clinical Decision Support, Predictive – Houston, TX

Biostate AI closes $12M to bring the Netflix model to molecular diagnostics

SKRIBER: AI, Soft/SaaS, Scribe – Pasco, WA

Skriber Secures Oversubscribed $1.3M Pre-Seed Funding to Accelerate AI-Powered Medical Documentation Revolution

Axle Health: Soft/SaaS, Homecare – Los Angeles, CA

Axle Health Raises $10M To Accelerate AI Home-Based Care Tech Development

Palarum: Wearable, Fall Prevention, Nursing – Lebanon, OH

Palarum Raises $2M for Its Fall Prevention Wearable

Salvia BioElectronics: Procedural Device, Neurology, Migraine – Eindhoven, The Netherlands

Salvia BioElectronics secures $60M in oversubscribed Series B to bring its pioneering migraine therapy to market

Veyond Metaverse: AI, XR, Remote Presence – Castro Valley, CA

Veyond Metaverse Secures Strategic Funding to Accelerate Commercial Launch of SkyDoc and MaritimeDoc

AssistIQ: AI, Soft/SaaS, OR Supply & Implant Usage, – Montreal, QC

AssistIQ Raises $11.5 Million to Fix Supply Blind Spots with AI, Preventing Missed Charges and Avoidable Costs in Surgical and Procedural Care

PorTal Access: Procedural Device, Vascular Access – Miami, FL

Portal Access, Inc. Announces the closing of $7 Million Series A Financing Round to Support FDA Approval and Limited Market Launch of Next-Generation Chemotherapy Port

Neuralink: Implant, BCI, Neurology – Fremont, CA

Musk’s Neuralink raises fresh cash at $9 billion valuation, Semafor reports

Acclaro Medical: Procedural Device, Plastic Surgery – Smithfield, RI

Acclaro Medical Raises $23 Million in Series B Funding Led by Accelmed Partners to Advance Groundbreaking 2910 nm Fiber Laser Technology

Brainreader: Software, Image Analysis, Neurology, Brain – Aalborg, Denmark

Danish startup attracts $7.3M to develop clinical applications and broaden market reach

Pillar Biosciences: Diagnostic, Precision Medicine – Natick, MA

Pillar Biosciences Raises $34.5M in Funding

Neuralink: Implant, BCI – Fremont, CA

Musk’s Neuralink raises $650 million in latest funding as clinical trials begin

Regulatory

IDE
Atia Vision: Implant, IOL, Ophthalmic Surgery – Campbell, CA

FDA Grants Atia Vision Approval to Begin US Clinical Trial of OmniVu™ Lens System in Patients with Cataracts

Submittal
IdentifySensors Biologics: Diagnostic, POC, Infectious Disease, Ebola – Shaker Heights, OH

IDENTIFYSENSORS INITIATES FDA SUBMISSION PROCESS FOR DIGITAL DIAGNOSTICS PLATFORM

Approval
Phraxis: Procedural Device, Endovascular, Venous Anastomosis – Minneapolis, MN

Phraxis Announces FDA Approval of EndoForce™ Connector for Endovascular Venous Anastomosis, Advancing Dialysis Access Innovation

Approval
MSKai Spine: AI, Imaging, Lumbar Spine – Memphis, TN

MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use

Approval
AnX Robotica: AI, Imaging, Gastroenterology – Plano, TX

AnX Robotica Announces FDA 510(k) Clearance for MotiliCap™ and MotiliScan™: Next-Generation GI Motility Monitoring Solutions

Approval
Distalmotion: Robotics, Surgery, General, Cholecystectomy – Épalinges, Switzerland

Distalmotion Gains FDA 510(k) Clearance for Cholecystectomy, Further Advancing Access to Robotics in the Outpatient Setting with its DEXTER® Robotic Surgery System

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

Pearl Becomes First Dental AI Company Cleared by FDA for Both 2D and 3D Imaging

Approval
Empatica: Remote Pt. Monitoring, Neurology, Epilepsy – Cambridge, MA

Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe

Submittal
Visby Medical: Diagnostic, POC, Infectious Disease, Men’s Health – San Jose, CA

Visby Medical™ Submits Men’s Sexual Health Test to FDA for Clearance and CLIA Waiver

IDE
CoreMap: Diagnostic, Mapping, EP – Burlington, MA

CoreMap, Inc. Receives U.S. FDA Investigational Device Exemption (IDE) Approval for INvENI Map-Guided AF Ablation Study

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

HistoSonics’ Edison Histotripsy System Gains Great Britain Early Market Access Under Unmet Clinical Needs Authorisation

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

Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System

Approval
Lunit: AI, Imaging, Radiology – Seoul, South Korea

Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities

Approval
Reflow Medical: Procedural Device, Retriever Stent, Peripheral Vascular – San Clemente, CA

FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System

Approval
Clairity: AI, Predictive Medicine, Oncology, Breast – Boston, MA

ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women’s Health

Product News

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

Guardant Health Introduces Hereditary Cancer Testing to Identify Inherited Predispositions to Certain Types of Cancer

Innovaccer: AI, Soft/SaaS, Pt. Data Integration – San Francisco, CA

Innovaccer Launches ‘Innovaccer Gravity™’: The Healthcare Intelligence Platform to Accelerate AI-Driven Transformation

SAGA Diagnostics: Diagnostic, Liquid Biopsy, Oncology, Breast Cancer – Lund, Sweden

SAGA Diagnostics® Announces U.S. Commercial Launch of Pathlight™ at ASCO 2025, Setting a New Standard for Ultra-sensitive and Early MRD Detection

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

Guardant Health Introduces Nearly a Dozen Groundbreaking Smart Liquid Biopsy Applications for Guardant360 Liquid Test

Real Time Medical Systems: Soft/SaaS, Interventional Analytics – Baltimore, MD

Real Time Medical Systems Launches New Value-Based Care Solution, Delivering Live Post-Acute Care Insights

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

Viz.ai Expands AI Cancer Care Tools with AI-Powered Viz Oncology™ Suite

Tempus AI: AI, Soft/Saas, Clinical Assistant – Chicago, IL

Introducing Tempus One in the EHR with Integrated Guidelines

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

Tebra Launches AI Note Assist, Reducing Clinical Documentation Time by 50% for Independent Practices

Vitalacy: AI, Wearable, Infection Control – Los Angeles, CA

Vitalacy Debuts Gen5 Hand Hygiene Wearable with Improved Features

Breakthrough Devices

Hyprevention: Implant, Orthopedic Surgery, Spine Surgery – New York, NY

Hyprevention Y-STRUT Hip Implant granted as a Breakthrough Device by the FDA

BiVACOR: Implant, Artificial Heart – Huntington Beach, CA

BiVACOR’s Total Artificial Heart Receives FDA Breakthrough Device Designation

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

FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection (MCD) Test

Clinical Trials/Studies

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

New Study Finds RapidAI Significantly Outperforms Viz.ai in Detecting Medium Vessel Occlusions in Stroke Patients

Virtuoso Surgical: Robotics, Surgical, Endoscopic – Nashville, TN

Virtuoso Surgical Robotic System Used To Perform Successful First-in-Human Bladder Cancer Removal Cases: Enables Cutting Edge Surgical Approach

Vergent Bioscience: Imaging Agent, Surgery, Oncology – Minneapolis, MN

Vergent Bioscience Presents Phase 2B VISUALIZE Results Demonstrating Abenacianine for Injection (VGT-309) with Intraoperative Molecular Imaging Improved Tumor Visualization During Lung Surgery

Auxilium Biotechnologies: Implant, Neurosurgery, Nerve Regeneration – San Diego, CA

Auxilium Biotechnologies Launches Clinical Trial for Nerve Regeneration Medical Device

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

TRiCares presents promising First-In-Human Topaz data at EuroPCR 2025

Von Vascular: Procedural Device, Thrombectomy, Neurovascular, Pulmonary, Vascular – Sunrise, FL

Von Vascular Announces Publication of ALGO™ Smart Pump Study in Clinical Neurology and Neurosurgery

AION Biosystems: AI, Remote Pt. Monitoring, Oncology, Temperature – Lowell, MA

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

Progentec Diagnostics Cuts Lupus Classification Timeline by 80% In Virtual Study

Geneseeq: Diagnostic, Liquid Biopsy, Precision Medicine, Oncology – Toronto, ON

Geneseeq’s Breakthrough Cancer Detection Blood Test Published in Nature Medicine

Ontada: Soft/SaaS, Clinical Data Analysis. Colorectal Cancer – Boston, MA

Ontada Unveils Comprehensive Data on Social Determinants of Health and Outcomes of Early-Onset Colorectal Cancer at ASCO

ExThera Medical: Blood Filter, Infectious Disease – Martinez, CA

ExThera Medical’s Blood Filtration Device Shows Promise for Sepsis Patients After Cardiac Surgery

Brainomix: AI, Imaging, Neurovascular, Stroke – Oxford, UK

Brainomix Driving Treatment Decisions in Stroke: New Studies Presented at Leading European Stroke Conference

MedsEngine: Soft/Saas, Clinical Decision Support, Cardiology, Endocrinology – Beavercreek, OH

MedsEngine Achieves High Blood Pressure Control In Less Than Two Office Visits

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

New Data Shows NeXT Personal® Identifies Breast Cancer Patients Receiving Neoadjuvant Therapy that are at High Risk for Relapse

PanGIA: AI, Diagnostic Test, Urology, Prostate Cancer – Delray Beach, FL

PanGIA Biotech Unveils AI-Driven Urine Test Data for Early Prostate Cancer Detection at ASCO 2025

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

ERENA-6 Phase III Trial Demonstrates Clinical Value of Guardant360 CDx Test to Detect Emergence of Endocrine Resistance and Inform a Switch in Therapy Before Radiological Disease Progression in Advanced Breast Cancer

Freenome: Diagnostic, Cancer Screening – South San Francisco, CA

Freenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer

Precision Epigenomics: Diagnostic, Molecular, Oncology – Tucson, AZ

Precision Epigenomics Presents Validation of EPISEEK™, a Multi-Cancer Early Detection Test, at 2025 ASCO Annual Meeting

FastWave Medical: Procedural Device, Laser IVL, Interventional Cardiology – Brooklyn Park, MN

FastWave Medical Announces Successful First-in-Human Procedures in Study of Sola™, Its Next-Generation Coronary Laser IVL System

Jenscare Scientific: Implant, Heart Valve – Ningbo, China

Jenscare released 30-day follow-up results of LuX-Valve Plus TRINITY study and 1-year follow-up results of JensClip TMVr at EuroPCR 2025

Partnerships

Viz.ai: AI, Soft/SaaS, Diagnostic, COPD – San Francisco, CA
Sanofi: Pharmaceuticals – Paris, France

Viz.ai Announces Collaboration With Sanofi and Regeneron to Improve Management and Care of Chronic Obstructive Pulmonary Disease (COPD

Health Endeavors: AI, Soft/SaaS, POC, Pt. Benchmarking, Care Improvement – Scottsdale, AZ
Telescope Health: Telemedicine – Jacksonville, FL

Health Endeavors, Telescope Health Advancing Provider Analytics and Care Gap Solutions Through Strategic Partnership

Exo: AI, Diagnostic Ultrasound, Cardiology – Santa Clara, CA
Samsung Medison: Capital Equipment, Imaging, – Seoul, South Korea

Exo® Announces Samsung Medison Strategic Collaboration and Welcomes Omar Ishrak to its Board

Retrieve Medical: Soft/SaaS, Medical Records – Bedminster, NJ
MyID: Storage/Retrieval, Personal Health Records – St. George, UT

Retrieve Medical and MyID Form Joint Venture to Launch First-Ever Wearable Electronic Health Record

Lumea: AI, Diagnostic, Digital Pathology – Lehi, UT
AIxMed: AI, Diagnostic, Digital Cytology – Santa Clara, CA

AIxMed Partnership with Lumea Enhances Digital Pathology Platform with AI-Powered Urine Cytology Solution

Viz.ai: AI, Soft/SaaS, @orkflow, Oncology – San Francisco, CA
Novartis: Pharmaceuticals – Basel, Switzerland

Viz.ai Launches New Strategic Alliance to Accelerate Timely Diagnosis and Deliver AI-Powered Precision Care for Patients with Cancer

Foresight Diagnostics: Diagnostic, Oncology, Hodgkin Lymphoma (cHL) – Boulder, CO
Qiagen: Diagnostic Tests – Venlo, The Netherlands

Foresight Diagnostics and QIAGEN Announce Strategic Partnership to Advance Development of Companion Diagnostic Kits for Lymphoma

This & That

Human in Motion Robotics: Robotics, Exoskeleton, Pt. Mobility – Vancouver, BC

Human in Motion Robotics’ XoMotion™ Wins Prestigious TAG Award for MedTech Innovation

AI meets Health: 10 promising European startups leading the change in 2025

AI-based mammography is here, and it has a trust problem

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

Inspira Technologies Initiates Global Commercial Rollout of FDA-Cleared ART100 System

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

Twice a month, 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, FoxNews.com, HIT Consultant, Newswire, Investing, Access Newswire, MedicalXpress, Reuters, BioSpace, Tracxn, 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.