MedTech Startup Roundup – Vol.1 No.14

The news you need on MedTech startups

Dan’s Picks

SetPoint Medical: Implant, Neuroimmune Modulation – Valencia, CA

SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis

Kodiak Solutions: Soft/SaaS, RCM, Compliance – Indianapolis, IN

Medicaid disenrollments from the One Big Beautiful Bill Act could wipe out more than 70% of an average hospital’s net income, according to a Kodiak Solutions’ analysis

Product Launches

SetPoint Medical: Implant, Neuroimmune Modulation – Valencia, CA

SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis

Clear Labs: Soft/SaaS, Diagnostics, Lab-Based, Infectious Disease – San Carlos, CA

Clear Labs Launches Clear Dx™ Deeplex® Myc-TB, An Automated Solution for Mycobacterium Species Identification and TB Drug Resistance Mutations

Imbed Biosciences: Wound Matrix, Wound Care – Middleton, WI

Imbed Biosciences Launches Dual-Action Wound Matrix Integrating Bioburden Management and Pain Relief in a Single Solution

M&A

Acquisition
Wenzel Spine (Product): Implant, Spine Surgery – Austin, TX
Driving Force: Diagnostic, Spine Alignment Analysis – Lombard, IL

Driving Force Acquires Vertebral Motion Analysis (VMA®) Technology from Wenzel Spine

The Cs

Zephyr AI: AI, Clinical Decision Support – McLean, VA

Allen Chao, PhD – CEO (Joining)

Zephyr AI Appoints Watson Pharmaceuticals Founder Dr. Allen Chao as Chief Executive Officer

Vektor Medical: AI, Soft/SaaS, Arrhythmia Analysis – San Diego, CA

Kelly Perez – CFO and Sr. VP of Operations (Joining)

Vektor Medical Names Kelly Perez as CFO and SVP of Operations to Support Expanding vMap Adoption

Bioretec : Implant, Absorbable, Orthopedic Surgery – Tampere, Finland

Sarah van Hellenberg Hubar-Fisher – CEO (Joining)

Bioretec Appoints Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer

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

Shruthi Narayan – President (Promotion)

Penumbra, Inc. Names Shruthi Narayan as Company President

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

Jay Jennings – CFO (Joining)

QT Imaging Appoints Seasoned Accounting Executive as Chief Financial Officer

Perimeter Medical Imaging AI: AI, Imaging, Surgical – Dallas, TX & Toronto, ON

Ted James, MD – CMO – Medical (Joining)

Renowned Surgical Oncologist, Dr. Ted James, Joins Perimeter as Chief Medical Officer

Funding

Diag-Nose.io: AI, Diagnostic, Respiratory – Melbourne, Australia

Respiratory disease startups score $3 million to develop AI-powered treatment analysis

Barti: AI, Soft/SaaS, EHR, Ophthalmology, Optometry – San Francisco, CA

Barti Raises $12M Series A to Accelerate AI-Powered EHR for Eye Care

Lumaegis: Capital Equipment, Sterilization – Austin, TX

Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness

Avasa: Procedural Device, Microvascular Coupling, Vascular Surgery – Auckland, New Zealand

Auckland-based MedTech start-up Avasa has secured the first close of its Pre-Series-A capital raise

Assort Health : AI, Agentic, Generative, Soft/SaaS, Pt. Interaction, Multi-Specialty – San Francisco, CA

Assort Health nabs $50M to automate patient phone calls, sources say

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

QT Imaging Receives $5.0 Million in New Funding from Lynrock Lake to Repurchase and Cancel All Yorkville Warrants

PainTEQ: Implant, Allograft, Spine Surgery – Tampa, FL

PainTEQ Secures Majority Growth Recapitalization Co-Led by Signet Healthcare Partners & Windham Capital Partners

MedaSync: Soft/SaaS, Reimbursement, SNF – Cleveland, OH

MedaSync Secures Strategic Investment from Omega Healthcare Investors, Inc.

Berlin Heals Holding AG Successfully Raises Over 5Million USD Round for Advancing New Less Invasive Approaches

Regulatory

Approval
Brightonix Imaging: AI, Capital Equip, Imaging, PET, CT – Seoul, South Korea

Brightonix Imaging’s High-Performance ‘PHAROS’ PET Receives FDA Clearance

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

Arctx Medical Receives IDE approval from FDA for a Pivotal Clinical Trial of its ACC Kit for the Treatment of Acute Pancreatitis, Announces New Leadership

Approval
AliveDx : Diagnostic, In-Vitro Clinical Lab – Eysins, Switzerland

AliveDx registers MosaiQ®, its Instrument for Multiplex Testing of Autoimmune Diseases, Allergies and Beyond, as a Class II Exempt Device with the U.S. Food and Drug Administration (FDA)

IDE
Airiver Medical: Procedural Device, Drug-Coated Balloon, Airway Stenosis, Interventional Pulmonology – Brooklyn Park, MN

Airiver Medical Receives IDE Approval from the FDA for Pivotal Clinical Study of the Airiver Pulmonary Drug Coated Balloon to Treat Benign Central Airway Stenosis

CRL
Telix Pharmaceuticals: Diagnostic, Radiopharmaceutical, Cancer – Melbourne, Australia

FDA shares concerns about new imaging agent, sinking shares for radiopharma firm Telix

HCT/Ps Classification
BioLab Holdings: Biologic, Allograft – Phoenix, AZ

FDA’s Tissue Reference Group Recognizes Five New BioLab Holdings Amniotic Membrane Allografts as HCT/Ps

Product News

Optellum: AI, Imaging, Radiology, Lung Cancer – Oxford, UK

Optellum Debuts World’s First Thorax CT Foundation Model Built for Real-World Precision Lung Care

Relatient: AI, Agentic, Soft/SaaS, Pt. Scheduling – Atlanta, GA

Relatient Voice AI Deflects More Than 60% of Routine Appointment Scheduling Calls

Aztron Medtech: Procedural Device, Achilles Tendon Repair, Foot & Ankle Surgery – Taipei City, Taiwan

Aztron Medtech Completes 50th U.S. TendMIN™ Procedure in Minimally Invasive Achilles Repair, Signaling Strong Early Adoption

Olleyes: VR, Eye Exam, Ophthalmology, Optometry – Summit, NJ

Olleyes, Inc. Expands VisuALL Virtual Reality Platform With Breakthrough Stereopsis Test

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

Phraxis Announces First-Ever Commercial Case of EndoForce™ Anastomotic Connector at Spartanburg Regional Medical Center

Reimbursement

Gel4Med: Biomimetic Matrix, Wound Care – Boston, MA

CMS Assigns HCPCS Level II Code A2037 to Gel4Med’s G4Derm™ Plus

Clinical Trials/Studies

Pulse Biosciences: Procedural Device, Bioelectric Medicine, PFA, Oncology, Cardiology – Hayward, CA

Pulse Biosciences Announces Publication of First-In-Human Data for Treatment of Benign Thyroid Nodules in the Journal Thyroid

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

Arctx Medical Receives IDE approval from FDA for a Pivotal Clinical Trial of its ACC Kit for the Treatment of Acute Pancreatitis, Announces New Leadership

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

BillionToOne’s Northstar Select® Demonstrates Superior Sensitivity in Prospective Head-to-Head Validation Study Publication

Orchestra Biomed: Procedural Device, Cardiology, Hypertension – New Hope, PA

Orchestra BioMed Announces Publication of Clinical Data Demonstrating Favorable Blood Pressure and Hemodynamic Effects of AVIM Therapy in JACC: Clinical Electrophysiology

Airiver Medical: Procedural Device, Drug-Coated Balloon, Airway Stenosis, Interventional Pulmonology – Brooklyn Park, MN

Airiver Medical Receives IDE Approval from the FDA for Pivotal Clinical Study of the Airiver Pulmonary Drug Coated Balloon to Treat Benign Central Airway Stenosis

MolecuLight: Imaging, Surgical Wound Care – Toronto, ON

Large Independent Randomized Controlled Trial Validates MolecuLight’s Transformative Impact on Wound Debridement, Showing Improved Outcomes and Lower Costs

Breath Diagnostics: Diagnostic, Predictive – Louisville, KY

Breath Diagnostics Technology Demonstrates Breakthrough in Predicting Pneumonia Through Exhaled Breath Analysis

Partnerships

SimBioSys: 3D spatial visualizations, Breast Cancer – Chicago, IL
Ricoh 3D for Healthcare: Soft/SaaS. Surgical Planning, Anatomic Models – Tokyo, Japan

SimBioSys and Ricoh 3D for Healthcare announce strategic alliance expanding access to TumorSight™ Viz for breast cancer surgery

Patents

Neurobit: AI, Diagnostic, Predictive Medicine, Sleep – New York, NY

Neurobit Secures US Utility Patent for AI-Powered Diagnostic System

Catheter Precision: Procedural Device, E-P – Fort Mill, SC

Catheter Precision Receives Notification of New Patent Issuance for VIVO Product Line

This & That

Waystar: AI, Soft/SaaS, RCM – Louisville, KY

Waystar Named Healthcare Company of the Year and Top-Ranked AI Software Platform in the 2025 Stevie® Awards

Berlin Heals: Implant, Electroceutical, Cardiology, Heart Failure – Berlin, Germany

Investors Are Flocking To Fund Incontinence-Focused Startups

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.