MedTech Startup Roundup – Vol.2 No.16

Acquisition
Amplitude Vascular Systems: Procedural Device, IVL, Peripheral Vascular – Waltham, MA
Stryker: Multiple Product Lines – Portage MI

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio

Acquisition
Sectra: Soft/SaaS, Imaging – Linköping, Sweden
Oxipit: AI, Soft/SaaS, Imaging Interpretation – Vilnius, Lithuania

Sectra completes Oxipit acquisition, accelerating autonomous AI in radiology

Acquisition
Robocath: Robotics, Interventional, Cardiovascular, Neurovascular – Rouen, France
Stereotaxis: Capital Equip, Surgical Navigation – St. Louis, MO

Stereotaxis Announces Definitive Agreement to Acquire Robocath

Acquisition
SAGA Diagnostics: Diagnostic, Liquid Biopsy, Oncology, Breast Cancer – Lund, Sweden
Foundation Medicine: Diagnostic, Precision Medicine – Cambridge, MA

Sciety portfolio company Saga Diagnostics acquired by Foundation Medicine, a subsidiary of Roche

The Cs

Boston Aesthetics: Capital Equip., Aesthetics, Skin Tightening – Irvine, CA

Brandon Nye – CEO (Joining)

Boston Aesthetics Appoints Brandon Nye as Chief Executive Officer to Drive Next Phase of Commercial Growth

Accuity : AI, Soft/SaaS, RCM – Mount Laurel, NJ

Cindy Klain – CPO – Product & CSO – Strategy (Joining)

Accuity Names Cindy Klain Chief Product and Strategy Officer to Advance Innovation and Growth

Iris Telehealth: Telemedicine, Behavioral Health – Austin, TX

Donna Robinson – CGO – Growth (Joining)

Iris Telehealth Marks a New Chapter in Behavioral Health with Launch of Iris Insights and Appointment of Chief Growth Officer

Caristo Diagnostics: AI, Diagnostic, Image Analysis, Coronary Artery Disease – Oxford, UK

Stephen Deitsch – CEO (Joining)

Caristo Diagnostics Appoints Stephen Deitsch as Chief Executive Officer

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

Yoav Rozanovich – CBO – Business (Joining)

Inspira Technologies Appoints Yoav Rozanovich as Chief Business Officer to Drive Immediate Revenue Growth and Quantum Expansion

AmplifyMD: Soft/SaaS, Virtual Pt. Care – Los Gatos, CA

Kurt Blasena – CCO (Joining)

AmplifyMD Names Health Tech Veteran Kurt Blasena as Chief Commercial Officer

Board Members

CubitDx: Diagnostic, POC, Molecular, Immunoassay – Carlsbad, CA

Robert Bujarski – Board Member (Joining)
Mark Paiz – Board Member (Joining)

CubitDx Appoints Robert Bujarski and Mark Paiz to Board of Directors to Support Next Phase of Growth

Myomo: Robotics, Wearable, Orthotic, Arm – Burlington, MA

William J Febbo – Board Member (Joining)

Myomo Appoints William J Febbo to its Board of Directors

Funding

Remission Medical: Virtual Medicine, Rheumatology – Richmond, VA

Remission Medical Closes Series A Led by Blue Heron Capital to Expand Virtual Rheumatology Partnerships Across U.S. Health Systems

Ultralight Health: Ai, Soft/Saas, Practice Operating System – San Francisco, CA

Ultralight Raised $9.3M

Calyxo: Procedural Device, Endourology, Stone Removal – Pleasanton, CA

Calyxo Secures $40 Million Series F Financing as CVAC System Surpasses 40,000 Patients Treated for Kidney Stone Removal

HeartBeam: DME, 3D ECG – Santa Clara, CA

HeartBeam Announces Proposed Public Offering of Common Stock

NightWare: Digital Therapeutic, PTSD – Hopkins, MN

EXIT 156 CAPITAL AND NIGHTWARE ANNOUNCE STRATEGIC INVESTMENT PARTNERSHIP

Wavelet : AI, Diagnostic, Fetal Monitor – Brooklyn, NY

Aegis Ventures and Wavelet Medical Aim to Redefine the Standard of Care in Fetal Medicine

Keebler Health: AI, Software/SaaS, Risk Adjustment, Clinical Decision Support – Durham, NC

Keebler Health Raises $16M to Unlock Unstructured Clinical Data for the Next Generation of Risk Adjustment, Population Health, and RADV Audit Readiness

Sonire Therapeutics: HIFU, Prostate Cancer – Tokyo, Japan

Sonire Therapeutics Closes $18 Million Series A Financing to Advance Breakthrough HIFU Therapy for Pancreatic Cancer, Expands U.S. Clinical Development

AmplifiDX: Diagnostic, POC – Newark, CA

Shepherd Ventures III portfolio company AmplifiDX Secures Added Non-Dilutive Funding

HeartBeam: DME, 3D ECG – Santa Clara, CA

HeartBeam Announces Closing of $10 Million Public Offering of Common Stock

ONWARD Medical: Neuromodulation and BCI – Eindhoven, The Netherlands

ONWARD Medical Successfully Raises over EUR 40 Million in Capital Increase

Worki: AI, Soft/SaaS, Operations, Workforce, HR – San Francisco, CA

Worki Raises $2.75 Million to Build the AI Workforce Unifying Infrastructure Layer for Healthcare Workforce Operations

Ethermed: AI, Soft/SaaS, Prior Authorization – Philadelphia, PA

Ethermed Raises $8.5 Million Series A, Bringing Total Funding to $15M+, to Accelerate AI-Powered Prior Authorization

Proteins.1: Diagnostic, Single-mmolecule Protein Amplification – Espoo, Finland

VTT-originated startup Proteins.1 launches to bring PCR-like amplification and simplicity to omics

Joyful Health: Soft/SaaS, Financial Operating System – New York, NY

Joyful Health Raises $22M to Help Healthcare Providers Recover Billions in Unpaid Insurance Claims

ScreenPoint Medical: AI, Soft/SaaS, Imaging, Breast – Nijmegen, The Netherlands

ScreenPoint Medical Secures $16M to Lead the Next Phase of AI in Breast Cancer Care

Regulatory

Approval
Protaryx Medical: Procedural Device, Transseptal Puncture, Cardiac Surgery, Interventional Cardiology – Baltimore, MD

Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device

Approval
Scopio Labs : AI, Diagnostic, Imaging, Hematology – Tel Aviv, Israel

Scopio Labs Secures EU IVDR Certification for the Industry-Only Full-Field Digital Bone Marrow Application

Approval
Reach Surgical: Procedural Device, Minimally-Invasive, Surgical Stapling – Singapore

Reach Surgical Receives CE Mark Approval for iREACH IRIS, First Powered Reusable Stapler with Real-Time Firing Curve™ and 90° Articulation

Approval
Bunkerhill Health: AI, Reasoning, Soft/SaaS, Diagnostic, Cardiology, Workflow – San Francisco, CA

Bunkerhill Health Secures CMS Reimbursement Pathway for AI Cardiovascular Analysis, Receives FDA Clearance for the First AI Algorithms to Evaluate Coronary and Aortic Valve Calcium on Contrast-Enhanced Chest CTs

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

Cala Announces FDA Clearance of its Next Generation TAPS Therapy Wearable Device for Essential Tremor and Parkinson’s Disease

Approval
SurGenTec: Implant, Spine Surgery – Boca Raton, FL

SurGenTec Secures FDA 510(k) Clearance for TiLink™ SI joint fusion- Now Navigation Compatible

Approval
FertilAI : AI, Predictive, Fertility – Giv’atayim, Israel

FertilAI Secures World’s First CE Mark for Predictive AI in Fertility Treatment Cycle Optimization

IDE
Phantom Neuro: ML, Human/Machine Interface, Prosthetics – Austin, TX

Phantom Neuro Receives Approval for First-In-Human Clinical Study

Approval
Waiv: AI, Diagnostic, Precision Medicine – Paris, France

Waiv Achieves Dual CE Marking Under IVDR, Propelling AI Precision Testing for Breast and Colorectal Cancer for Clinical Routine

Approval
Rapid Medical: Procedural Devices, Neurovascular – Yokneam Illit, Israel

Rapid Medical™ Announces FDA Clearance of TIGERTRIEVER™ 25 and First Clinical Cases

Approval
Corify Care: Imaging, Cardiac Mapping, EP – Madrid, Spain

Corify Care Receives FDA Clearance for ACORYS® — Introducing Instant, 4-D Electroanatomical Cardiac Mapping in Real-time

Product News

RapidClaims: AI, Software/SaaS, RCM – New York, NY

RapidClaims Expands RCM Platform with RapidRecovery, Completing an Integrated Revenue Cycle from Clean Claim to Denial Resolution

Harbinger Health: Diagnostic, Liquid Biopsy, Oncology – Cambridge, MA

Harbinger Health Establishes RESOLVE™ as a New Category for Cancer Detection

Nymbl Systems: Soft/SaaS, Practice Mgt. – Dublin, OH

Nymbl Launches Parachute Health Integration to Automate Order Intake and Accelerate Patient Fulfillment

QT Imaging : Imaging, Breast, Radiology – Novato, CA

QT Imaging Debuts the QT Imaging-Olea Viewer for Integrated, Multimodality Breast Imaging Within a Single User Interface

Abridge: AI, Soft/SaaS, Scribe – Pittsburgh, PA

Abridge Partners with NEJM and JAMA to Integrate Peer-Reviewed Evidence Shaped by Clinical Conversations

Breakthrough Devices

TOBY: Diagnostic Test, Cancer – Boston, NY

TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Multi-Cancer Early Detection (MCED) Test

Reimbursement

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

CMS Accepts Innovaccer for the ACCESS Model, Giving Health Systems a Zero-Risk Path to Medicare’s Chronic Care Revolution

Bunkerhill Health: AI, Reasoning, Soft/SaaS, Diagnostic, Cardiology, Workflow – San Francisco, CA

Clinical Trials/Studies

Genialis: Predictive Medicine, Breast Cancer Response – Boston, MA

Genialis Supermodel Predicts Patient Response to HER2-Targeted Therapy Enhertu

Natera: Diagnostic, Liquid Biopsy, Genetic Testing, Oncology, Women’s Health, Transplant – Austin, TX

Natera Highlights Positive Interim Futility Analysis from Allogene Therapeutics’ MRD-Guided ALPHA3 Trial in Large B-Cell Lymphoma

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

New STORM-PE Data Show Computer Assisted Vacuum Thrombectomy with Anticoagulation Resulted in Significantly Better Functional Outcomes at 90 Days Compared to Anticoagulation Alone for Pulmonary Embolism Patients

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

Reflow Medical Announces 12-Month Results from DEEPER REVEAL Trial: Sustained Outcomes with the Spur® Stent System in CLTI

SinglePass: Procedural Device, Biopsy Closure – Lake Forest, CA

SinglePass Study Reaches 500 Cases as Adoption Expands Across Biopsy Workflows

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

Atia Vision Announces Durable 36-Month Results from First-in-Human Study of their Dynamic Shape-Changing OmniVu Intraocular Lens System

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

New Case Study: bioAffinity Technologies’ CyPath® Lung Diagnostic Supports Physician’s Assessment, Prompts Follow-Up Imaging and Defers Unnecessary Biopsy

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

Imperative Care Initiates ADAPT 2.0 Study Evaluating Advanced Clinical Technique Designed to Simplify Acute Ischemic Stroke Treatment

Novigenix AI : Liquid Biopsy, Diagnostic, Precision Medicine, Oncology – Epalinges, Switzerland

Novigenix AI to Present Clinical Data at AACR 2026 Linking Immuno-Pharmacodynamics to Radioligand Therapy Response

Vitestro: Robotic, Autonomous Blood Draw – The Netherlands

Vitestro Publishes Landmark Peer-Reviewed Multicenter Clinical Study of Autonomous Robotic Phlebotomy in Clinical Chemistry

Belay Diagnostics: Diagnostic, Test, Liquid Biopsy – Chicago, IL

CSF Liquid Biopsy May Help Clarify Inconclusive Leptomeningeal Disease Cases, Study Finds

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

Axena Health: Non-Invasive Device, Urinary & Fecal Incontinence, Women’s Health – Auburndale, MA

Randomized Controlled Trial Published in Urogynecology Demonstrates Leva® Pelvic Health System’s Efficacy in Treating Fecal Incontinence

Kerecis: Skin Graft, Wound Care – Ísafjörður, Iceland

Clinical Trial Shows that Treatment with Kerecis Intact Fish-Skin Grafts Shortens Hospital Stays for Severely Burned Patients

PreludeDx: Diagnostic, Decision Support, Oncology, Breast Cancer – Laguna Hills, CA

AidaBREAST™ Multi-Omic Assay Demonstrates Spatial Proteomics for Clinical Oncology

Partnerships

3DR Labs: Imaging, 3D, Soft/SaaS – Louisville, KY
Combinostics: AI, Imaging, Neurological – Tampere, Finland

3DR Labs and Combinostics Streamline Neuroradiology Workflows with AI-Powered Brain Quantification

4D Path: Predictive Medicine, Diagnostic, Oncology – Newton, MA
Daiichi Sankyo: Pharmaceuticals – Tokyo, Japan

4D Path Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Predictive Biomarkers for an Antibody Drug Conjugate Program

BostonGene: AI, Diagnostic, Precision Medicine – Waltham, MA
ImmunoGenesis: Biopharma, Immuno-Oncology – Houston, TX

BostonGene and ImmunoGenesis Announce Strategic Partnership to Overcome Immunotherapy Resistance

Ellipsis Health: AI, Voice Agents, Soft/SaaS, Care Mgt – San Francisco, CA
Clearstep: AI, Soft/SaaS, Self-Triage, Care Navigation – Chicago, IL

Ellipsis Health and Clearstep Partner to Advance Clinically Intelligent Care Management

Tempus AI: AI, Soft/SaaS, Diagnostic, Cardiology, Clinical Assistant – Chicago, IL
Predicta Biosciences: Diagnostic Test, Multiple Myeloma, Blood Cancer, Autoimmune Disease – Boston, MA

Tempus and Predicta Biosciences Announce Collaboration to Expand Life Sciences Access to Ultrasensitive Whole-Genome Sequencing Assay for Hematologic Malignancies and MRD Monitoring

Vivo Care: RPM, CCM – Austin, TX
Onpoint Healthcare Partners: AI, Soft/SaaS, Workflow – Irving, TX

Onpoint Healthcare Partners and Vivo Care Announce Strategic Partnership to Advance Continuous, Patient‑Centered Care

Patents

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

BRAINBox Solutions Announces Expansion of Patent Portfolio Covering Diagnostic and Prognostic Technology for Concussion and Neurodegenerative Disease Tests

Legal Battles

Heartflow: AI, Imaging, Cardiology, Cardiovascular – Mountain View, CA
Cleerly: AI, Imaging, Cardiovascular – Denver, CO

Heartflow Files Patent Infringement Lawsuit Against Cleerly

This & That

Lunit: AI, Imaging, Radiology, Predictive Medicine, Oncology – Seoul, South Korea

Lunit Surpasses 330+ Sites and 1M Annual Screenings as Breast Imaging AI Moves into Clinical Practice

myHealthTrack: Digital Health, MSK, Cardio-Metabolic, Behavioral Health – San Diego, CA

myHealthTrack Accepted Into CMS’s Landmark ACCESS Model for Chronic MSK Care

Asset Acquisitions/Sales

Augmedics: AR, Surgical – Arlington Heights, IL
VB Spine: Implant, Spine, Intraoperative Visualization – Leesburg, VA

VB Spine Completes Transaction of Augmented Reality Spine Platform from Augmedics

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.