MedTech Startup Roundup – Vol.1 No.19

The news you need on MedTech startups

Dan’s Picks

Neteera: Diagnostic, Pt. Monitoring – Contactless – Jerusalem, Israel

Study Results Show Neteera Patient Monitoring System Successfully Alerted for 77% of Hospitalizations, Aiding Timely Intervention

Clearmind Biomedical: Procedural Device, Endoscope, Neurosurgery, Intracerebral Hemorrhage – Taipei, Taiwan

Clearmind Biomedical Signs Exclusive U.S. Distribution Agreement with Sutter Medical Technologies USA and launches the Neuroblade System at Congress of Neurological Surgeons (CNS) Los Angeles, CA.

Product Launches

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

Real Time Medical Systems Launches TEAM Insights to Support Providers in CMS’s New Value-Based Care Initiative

Ambience Healthcare: AI, Ambient, Soft/SaaS, Clinical Documentation – San Francisco, CA

Ambience Healthcare Becomes First Ambient AI Platform to Launch Inpatient CDI at the Point of Care, Built on OpenAI

Smarter Technologies: AI, Soft/SaaS, Revenue Cycle Mgt – Dallas, TX

Smarter Technologies Acquires Pieces Technologies and Launches SmarterNotes: The First Clinical AI Solution to Unite Inpatient Documentation with Revenue Cycle Intelligence

Yosi Health: AI, Soft/SaaS, Pt. Intake – New York, NY

Yosi Health Launches AI Voice Agent to Power Safer, Smarter Digital Front-Door Experiences

ChoiceSpine: Implants, Spine Surgery – Knoxville, TN

ChoiceSpine™ Announces Line Extension of TigerShark™ Lateral Interbody System

Doctible: Soft/SaaS, Pt. Engagement, Scheduling – San Diego, CA

Doctible Launches Patient Link and Doctible Websites: A Unified Growth Engine for Healthcare Practices

Freed: AI, Software/SaaS, Scribe – San Francisco, CA

Freed Unveils EHR Push: One-Click AI Note Transfer Into Any Web-Based EHR

BoomerangFX: Soft/SaaS, Practice Mgt and Marketing – Miami, FL

BoomerangFX Launches Global Rollout of Financial Services in Healthcare SaaS Solution with Stripe, Klarna, and Affirm

Clearmind Biomedical: Procedural Device, Endoscope, Neurosurgery, Intracerebral Hemorrhage – Taipei, Taiwan

Clearmind Biomedical Signs Exclusive U.S. Distribution Agreement with Sutter Medical Technologies USA and launches the Neuroblade System at Congress of Neurological Surgeons (CNS) Los Angeles, CA.

M&A

Acquisition
Pieces Technologies: AI, Soft/Saas, RCM – Irving, TX
Smarter Technologies: AI, Soft/SaaS, Revenue Cycle Mgt – Dallas, TX

Smarter Technologies Acquires Pieces Technologies and Launches SmarterNotes: The First Clinical AI Solution to Unite Inpatient Documentation with Revenue Cycle Intelligence

PKG Health: Wearables, Neurology – Melbourne, Australia
Empatica: AI, Remote Pt. Monitoring, Wearables, Neurology, Epilepsy – Cambridge, MA

Empatica Acquires PKG Health to Transform Parkinson’s Disease Monitoring

The Cs

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

Lisa Gurry – CBO – Business (Joining)

GeneDx Appoints Lisa Gurry as Chief Business Officer to Unlock Data and Information Growth

SpectraWAVE: Imaging, Cardiovascular – Bedford, MA

Jonathan Hill, MD – CMO – Medical (Joining)

SpectraWAVE Appoints Dr. Jonathan Hill, MD as Chief Medical Officer

Iris Telehealth: Telemedicine, Behavioral Health – Austin, TX

David Bartley – CSO – Solutions (Joining)

Iris Telehealth Appoints Healthcare Product Veteran David Bartley as Its First Chief Solutions Officer

Predicta Biosciences: Diagnostic Test, Multiple Myeloma, Blood Cancer, Autoimmune Disease – Boston, MA

Brian McKernan – CEO (Joining)

Predicta Biosciences Secures $23.4M to Scale its Novel Diagnostic and Analytics Platform for Blood Cancers and Autoimmune Diseases

TruBridge: Soft/SaaS, RCM, EPR, Population Mgt. – Mobile, AL

Michael Daughton – CBO – Business (Joining)

TruBridge Names Michael Daughton as Chief Business Officer to Advance Mission of Strengthening Rural and Community Healthcare

Board Members

CorVista Health: Diagnostic, POC, Cardiology, Pulmonary Hypertension – Bethesda, MD

Guido Neels – Board Member (Joining)
Dino Trevisani – Board Member (Joining)

CorVista Health Appoints Guido Neels and Dino Trevisani to Board of Directors

Funding

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

bioAffinity Technologies Announces Pricing of $4.8 Million Public Offering

Clearwater: AI, Soft/SaaS, Cybersecurity, Compliance – Nashville, TN

Clearwater Receives Strategic Growth Investment from Sunstone Partners

AiM Medical Robotics: Robotics, Imaging, Neurosurgery – Worcester, MA

AiM Medical Robotics Secures $8.1 Million Series A Financing to Transform Neurosurgery with MRI-Compatible Surgical Robotics

Confido Health : AI, Voice Agents – Jersey City, NJ

Confido Health raises $10M to expand AI voice agents beyond scheduling, transforming healthcare’s most common patient front door

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

Assort Health Secures $102 Million to Scale Nation’s First Agentic AI Platform That Solves Longstanding Frustrations Tied to Patient Access and Experience

Spineart: Implant, Spine Surgery – Geneva, Switzerland

Spineart secures CHF 25M investment to boost global growth

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

QT Imaging Announces $18 Million Private Placement Financing to Accelerate Growth

Predicta Biosciences: Diagnostic Test, Multiple Myeloma, Blood Cancer, Autoimmune Disease – Boston, MA

Predicta Biosciences Secures $23.4M to Scale its Novel Diagnostic and Analytics Platform for Blood Cancers and Autoimmune Diseases

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

GeneDx Announces First U.S. National Genomic Newborn Screening Initiative Launched with $14.4 Million NIH Award

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

DermaSensor Secures $16M to Scale AI-Powered Skin Cancer Detection in Primary Care

Koda Health: Soft/SaaS, Pt. Care Guidance – Houston, TX

Koda Health Oversubscribes a $7 Million Series A to Scale National Footprint as Regulatory Tailwinds Drive Adoption

Midi Health: Telemedicine, Women’s Health, Menopause – Palo Alto, CA

Midi Health Accelerates Mission, Closing $60M Series B Round Led by Emerson Collective

Kihealth: Diagnostic, Endocrinology, Diabetes – St. Augustine, FL

Kihealth Raises $5M in Oversubscribed Seed Round to Launch First-of-Its-Kind Diabetes Diagnostic

Regulatory

Approval
Outlook Surgical: Procedural Device, Surgical Endoscopy, Head & Neck – Bloomington, IL

Outlook Surgical Obtains FDA 510(k) Clearance for Hybrid Endoscope: A Breakthrough in Surgical Visualization

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

UroViu Receives FDA 510(k) Clearance for Its UV5000 Advanced Endoscope Platform

Approval
Zenflow: Procedural Device, Disposable, Urology, BPH – South San Francisco, CA

Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope

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

Submittal
C2N Diagnostics: Diagnostic, Neurology, Alzheimer’s – St. Louis, MO

C2N Submits U.S. FDA Regulatory Filing for Its Alzheimer’s Disease Blood Test

Submittal
MindRhythm: Diagnostic, Neurology, Stroke, Pre-Hospital – Cupertino, CA

MindRhythm’s Harmony for Prehospital Large Vessel Occlusion Stroke Identification Submitted for FDA Clearance

Submittal
Molecular Designs: Diagnostic, Molecular – Birmingham, AL

Molecular Designs Submits Simplicity™DX Respiratory Panel for FDA 510(k) Clearance

IDE
AorticLab: Procedural Device, Interventional Cardiology, Embolic Protection – Turin, Italy

AorticLab Receives FDA Approval to Initiate FLOWer™ Clinical Pivotal Investigation

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

IceCure Medical’s ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care

Product News

Relief Cardiovascular: Implant, Transvascular, Diagnostic, Therapeutic, CHF – Costa Mesa, CA

Relief Cardiovascular Announces First-in-Human Procedures with World’s First Transcatheter Smart Implant for the Treatment of Congestion in Heart Failure

Breakthrough Devices

Aidoc: AI, Imaging, Radiology – Tel Aviv, Israel

Aidoc Receives FDA Breakthrough Device Designation for First-of-Kind AI Solution Spanning Numerous Acute Conditions in CT

Reimbursement

Cleerly: AI, Imaging, Cardiovascular – Denver, CO

UnitedHealthcare and Cigna Coverage for Cleerly LABS Advanced Plaque Analysis Begins October 1st

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

Bioretec’s RemeOs™ Screw LAG Solid Receives CMS Transitional Pass-Through Payment in the US

Prenosis: AI, Diagnostic, Infectious Disease, Precision Medicine, Sepsis, Immunology – Chicago, IL

New ICD-10-PCS Code Available for AI Sepsis Diagnostic Tools

Clinical Trials/Studies

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

Spur® Elute DEEPER CORONARY Study Completes Enrollment

Autonomix Medical: Procedural Device, Nerve Ablation, Guided, Transvascular – The Woodlands, TX

Autonomix Medical, Inc. Initiates Good Laboratory Practice (GLP) Study for Sensing and RF Ablation System

VIVEX Biologics: Allograft, Spine, Orthopedic, Wound, Burn – Miami, FL

Vivex Biologics Treats First Patient in its Restore Trial Evaluating VIA Disc NP™ for Patients with Degenerative Disc Disease

RefleXion Medical: Capital Equip, Radiation Therapy, FDG-Guided – Hayward, CA

RefleXion Medical Announces First Clinical Outcomes for SCINTIX Therapy in Lung and Bone Tumors

Inflammatix: Diagnostic, POC, Infectious Disease – Sunnyvale, CA

Inflammatix Announces Three Landmark Publications in Nature Medicine that Redefine Acute Infection and Sepsis Diagnosis and Treatment

Neteera: Diagnostic, Pt. Monitoring – Contactless – Jerusalem, Israel

Study Results Show Neteera Patient Monitoring System Successfully Alerted for 77% of Hospitalizations, Aiding Timely Intervention

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

Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia

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

Pioneering the Future of Heart Health: Biograph and Caristo Diagnostics Announce First-of-its-Kind U.S. Study to Advance AI-Powered Prevention

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

GeneDx Announces First U.S. National Genomic Newborn Screening Initiative Launched with $14.4 Million NIH Award

Materna Medical : DME, Pelvic Floor Preparation for Childbirth, Women’s Health – Mountain View, CA

Materna Medical Presents Interim Data Advancing Understanding of Dilation Therapy on Vaginismus and Related Painful Sex at NPWH Annual Meeting

AorticLab: Procedural Device, Interventional Cardiology, Embolic Protection – Turin, Italy

AorticLab Receives FDA Approval to Initiate FLOWer™ Clinical Pivotal Investigation

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

Precision Neuroscience Reports First High-Bandwidth Brain–Computer Interface Achieved Without Open Surgery

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

Curonix Publishes Results for the First and Only IDE PNS Multi-Center Randomized Clinical Trial Resulting in an FDA 510(k) Expanded Indication for Treating Chronic Craniofacial Pain

Partnerships

Mopec: Diagnostic, Disposable, Capital Equip, Pathology – Madison Heights, MI
Lumea: AI, Diagnostic, Digital Pathology – Lehi, UT

Mopec Expands Partnership with Lumea to Deliver Seamless Digital Pathology Integration and Consumables Access

Patents

Humacyte: Implant, Regenerative Human Tissues – Durham, NC

Humacyte Announces Expansion of Intellectual Property for Pipeline Products with Granting of New U.S. Patent for Bioengineered Esophagus

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

Catheter Precision, Inc. Announces Two New Patents to be Issued by USPTO

Laguna Diagnostics: Diagnostic, Rapid – Irvine, CA

Laguna Diagnostics Awarded Second U.S. Patent for Rapid Blood Tests to Differentiate Schizophrenia and Bipolar Disorder, Expanding IP Portfolio in $3B Market

This & That

TeleSpecialists: Telemedicine, Neurology, Psychiatry – Fort Myers, FL

After Government Shutdown, Nation’s Largest Teleneurology Provider Warns Medicare Policy Lapse Threatens Access to Emergency Care

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.