MedTech Startup Roundup – Vol.2 No.14

The news you need on MedTech startups

Dan’s Picks

Clerio Vision: Capital Equip, Laser, Refractive Correction, Ophthalmology – Rochester, NY

Clerio Vision Secures Patent for “Enhanced LIRIC” Vision Correction Design

Hello!

Epia Neuro: BCI, Minimally Invasive, Post-Stroke Cognitive Recovery – San Francisco, CA

Epia Neuro Launches to Develop Intent-Driven Neural Technology to Restore Function After Stroke and Address Cognitive Decline

Product Launches

Ataraxis AI: Diagnostic, Predictive, Precision Medicine – New York, NY

Ataraxis AI Launches Ataraxis Breast CTX, the First Predictive AI Test Estimating Individualized Chemotherapy Benefit in Breast Cancer

Promptly: AI, Soft/SaaS, Pt. Experience – Miami, FL

Promptly Launches AI Fax to Automate Referral Processing for Specialty Clinics

Kolosis BIO: Implant, Bone Graft – Salt Lake City, UT

MTF Biologics® and Kolosis BIO® Launch the Latest Addition to the DBX Family: DBX® Fiber

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

Ambience Healthcare Launches Chart Chat for Nursing, the First EHR-Integrated Conversational AI Tool for Inpatient Nursing

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

QT Imaging Releases Its Next Generation Breast Imaging Reconstruction Software

Corti: AI, Agentic, Medical Coding – Copenhagen, Denmark

Corti Ships Symphony for Medical Coding with more than 25% Accuracy Edge Over OpenAI and Anthropic

Penguin Ai: AI, Soft/SaaS, Agentic AI – Palo Alto, CA

Penguin Ai Launches Gwen, a Build-Your-Own AI Platform for Healthcare Operations

restor3d: 3D Printing, Implants, Orthopedic – Durham, NC

restor3d Announces Full Commercial Release of the Aeros™ Modular Stem System

M&A

Merit Medical: Multiple Product Lines – South Jordan, UT
View Point Medical: Diagnostic, Cancer Localization – Carlsbad, CA

Merit Medical Acquires View Point Medical, Inc., expanding the Merit Therapeutic Oncology Portfolio

The Cs

CorWave: Implant, Cardiology, LVAD – Clichy, France

Andreas Fleischli – CTO (Joining)

CorWave Strengthens Its Leadership Team with Two Key Appointments

Science Corporation: BCI, Ophthalmology, Neurology, Physical Med – Alameda, CA

Murat Gunel, MD – CMO – Medical (Joining)

Science Corp. Appoints Murat Günel, MD, as Medical Director for Brain-Computer Interfaces

Curve Biosciences: Precision Medicine, Diagnostic, Chronic Disease – San Mateo, CA

Amit Singal, MD – CMO – Medical (Joining)

Curve Biosciences Appoints Dr. Amit Singal as Chief Medical Officer

PAVmed: Diagnostic, Digital Health – New York, NY

Joseph Virgilio – CBO – Business (Joining)

PAVmed Appoints Joseph Virgilio to Lead Relaunched Medical Device Portfolio

Funding

FIZE Medical: AI, Capital Equip, Fluid Mgt – Modi’in, Israel

FIZE Medical Announces $6 Million Warrant Exercise Bringing Total Series A Financing to $36 Million

Neurolief : Digital Medicine, Psychiatry, Depression – Netanya, Israel

Neurolief Secures Additional $6 Million Investment Following FDA Approval of Proliv™Rx, Expanding Access to Brain Neuromodulation Therapy for Patients with Inadequate Response to Antidepressants

Ambient Clinical Analytics: Soft/SaaS, Clinical Decision Support – Rochester, MN

Ambient Clinical Analytics Secures $5M Strategic Investment & Appoints Brian Tufts as CEO to Accelerate Growth of Clinical Analytics, Decision Support, & Workflow Tools

Avo: AI, Soft/SaaS, EHR Analysis – New York, NY

Avo Raises $10 Million Series A to be the Clinical AI Platform Powered by Trusted Knowledge

Sub-Q Bionics: Implant, Lymphatic Drainage System – Tel Aviv, Israel

Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care

VolitionRx: Diagnostic, Liquid Biopsy, Cancer – Henderson, NV

VolitionRx Secures EUR 2.0 Million of Non-Dilutive Funding from Regional Government Agencies in Belgium

Jimini Health: AI, Telemedicine, Behavioral – Stanford, CA

Jimini Health Raises $17M as Behavioral Health Systems Face Growing Pressure to Manage Patient AI Use with Clinical-Grade Infrastructure

Long Tail: Soft/SaaS, Reimbursement Recovery – Chicago, IL

Long Tail Secures Substantial Growth Investment from Eir Partners Capital

TimeSmartAI: AI, Soft/SaaS, Physician Contract Compliance – Kitchener, ON

TimeSmartAI Inc. Secures Strategic Investment to Scale Physician Contract Compliance Infrastructure for Leading Healthcare Systems

Acurion: AI, Diagnostic, Precision Medicine, Oncology – San Diego, CA

Acurion Closes Oversubscribed $4.3 Million Seed Round to Advance AI-Driven Precision Oncology Platform

StairMed Technology: BCI, Minimally Invasive – Shanghai, China

StairMed Secures RMB 500 Million Financing Led by Alibaba, Joined by Tencent

Aspect Biosystems: Implant, Bio-Printed Therapeutic – Vancouver, BC

Government of Canada announces $127 million investment in Aspect Biosystems and Providence Health Care to bolster the Canadian biomanufacturing and life sciences ecosystem

Insight Health: AI, Soft/SaaS, Agentic AI, Clinical – Austin, TX

Insight Health Raises $11M Series A Led by Standard Capital to Fix Healthcare’s Administrative Crisis

Regulatory

Approval
Butterfly Network: AI, Imaging, Ultrasound, POC – Burlington, MA

Butterfly Network Secures First FDA Clearance for Blind Sweep Ultrasound AI Tool, Marking a Major Stride for Women’s Health

Approval
4DMedical : Imaging, Soft/Saas, Cardiothoracic, Pulmonology – Melbourne, Australia

4DMedical receives CE Mark for CT:VQ™, enabling commercial launch across the European Union

IDE
i-Lumen Scientific: Device, Bioelectronic, Ophthalmology – Bloomington, MN

i-Lumen Scientific Receives FDA Approval of IDE to Initiate U.S. Enrollment in i-SIGHT2 Clinical Study for dry AMD

Approval
Restore Robotics: Service, Remanufacturing, Surgical Instruments – Panama City, FL

Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments

Approval
Genesys Spine: Implant, Spine, Spine Surgery – Austin, TX

Genesys Spine Announces Launch of the SIros-X™ System for Sacroiliac Joint Fusion and Pelvic Fixation of Pedicle Screw Constructs

Approval
Baebies: Diagnostic, Test, POC, Molecular – Durham, NC

Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

HDE
Serenity Medical: Implant, Stent, Neurovascular – Harrison, NY

Serenity Medical Receives U.S. FDA HDE Approval of the River™ Stent – the First Venous Stent Approved for Severe, Refractory Idiopathic Intracranial Hypertension (IIH)

IDE
VDYNE: Implant, Heart Valve, Transvascular – Maple Grove, MN

VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System

Approval
Zeto: Diagnostic, EEG – Raleigh, NC

Zeto Announces FDA 510(k) Clearance of Zeto New Wave™, Advancing Efficiency in Outpatient EEG

Approval
Allevion Medical: Procedural Device, Spinal Decompression – Boca Raton, FL

Allevion Medical™ Receives 510K Clearance for Vantage™ — A Fully Disposable Kit Featuring a Novel Approach to Spinal Decompression

Product News

Prevounce Health: AI, Remote Pt. Care – Indianapolis, IN

Prevounce Health’s Pylo 900-LTE Blood Pressure Monitor Earns Spot on AMA’s Validated Device Listing

Ellipsys Vascular: Procedural, Vascular Access System – San Clemente, CA

Ellipsys Vascular Access System to Return to U.S. Market in 2026

Moyae: AI, Soft/SaaS, EHR, Ophthalmology – Austin, TX

Moyae Adds Speech-to-Text to Its Ophthalmology EHR

Reimbursement

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

RefleXion Secures Expanded Medicare Payment for SCINTIX Cancer Therapy

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

Imbed Biosciences Announces CMS Assignment of HCPCS Code A2040 for Microlyte® PainGuard™

Clinical Trials/Studies

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

BRAINBox Solutions Provides Updates on Clinical, Development, and Corporate Progress in BRAINBox TBI Concussion Diagnostic/Prognostic Test Program

CorVista Health: Diagnostic, Cardiology – Bethesda, MD

CorVista Health Demonstrates High-Sensitivity for Noninvasive Detection of CAD including INOCA (Ischemia with No Obstructed Coronary Arteries) at ACC.26

Cytovale: Diagnostic Test, Sepsis – San Francisco, CA

Peer-Reviewed Study Shows IntelliSep Influences ED Physicians’ Sepsis Diagnostic Decisions

Emboline: Procedural Device, Embolic Protection, Interventional Cardiology – Santa Cruz, CA

Emboline Announces Positive Pivotal PROTECT H2H Trial Results for Emboliner® Presented as a Late-Breaking Clinical Trial at ACC 2026

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

HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)

VolitionRx: Diagnostic, Liquid Biopsy, Cancer – Henderson, NV

Volition Announces Mayo Clinic Study Demonstrates Nu.Q® Concentrations are Elevated in Trauma Patients

Acorai: Diagnostic, Non-Invasive Hemodynamic Monitoring, Heart Failure, Cardiology – Helsingborg, Sweden

Acorai Announces First Patient Enrolled in 1,000-Patient HOSP-HF Study

Concept Medical: Procedural Device, Interventional, Peripheral Vascular – Tampa, FL

SirPAD: Primary Results confirm the safety and efficacy of Sirolimus Coated Balloon in PAD

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

SignateraTM MRD Identifies Breast Cancer Patients Who Can Forgo Surgery

Medasense: AI, Perioperative Pain Monitoring – Ramat Gan, Israel

Medasense and Jefferson Health to Collaborate on Study of Pain Monitoring Technology in Spine Surgery

Shape Memory: Procedural Device, Embolization, Peripheral Vascular – Santa Clara, CA

Shape Memory Medical Begins Enrollment in FLAGSHIP Study Evaluating Novel False Lumen Embolization Technology

Tempus AI: AI, Soft/SaaS, Diagnostic, Cardiology, Clinical Assistant – Chicago, IL

Tempus and Medtronic Announce ALERT Trial Results Showing AI-Driven EHR Notifications Improve Treatment for Significant Valvular Heart Disease

Dxcover: AI, Liquid Biopsy, Oncology – Glasgow, UK

Unprecedented Early-Stage Cancer Detection Presented at AACR 2026

Fluidx Medical Technology: Procedural, Vascular Embolization, Liquid – Salt Lake City, UT

Fluidx Medical Announces First Patient Treated with Novel Embolic Gel

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

PanGIA Biotech Announces Peer-Reviewed Study in Diagnostics Showing 97.8% Sensitivity in Detecting Prostate Cancer Using a Urine-Based Liquid Biopsy with Machine Learning

Partnerships

AI Med Consult: AI, Soft/SaaS, Pt. Engagement – St. Petersburg, FL
4th Dimension EMR: Soft/SaaS, EMR – San Diego, CA

AI Med Consult and 4D EMR Announce Strategic Partnership to Advance AI-Driven Patient Engagement and Practice Efficiency

Exactice Medical : Procedural Device, Cardiac Surgery – San Diego, CA
ImSonic Medical: Imaging, Ultrasound, Perioperative. Surgical Planning – Blaine, WA

Exactice Medical and ImSonic Announce Product Development and Supply Agreement for AIM Device in Transseptal Procedures

WELL Health Technologies: RPM – Vancouver, BC
AliveCor: RPM, Cardiology – Mountain View, CA

WELL Health Partners with AliveCor to Bring AI-Powered Cardiac Monitoring and Cardiologist Oversight to Canadians

OpenEvidence: AI, Soft/SaaS, Clinical Information – Cambridge, MA
Tandem: AI, Soft/Saas, Prior Auth – New York, NY

OpenEvidence and Tandem Partner to Streamline Evidence-Based Prescribing and Prior Authorizations

Patents

Clerio Vision: Capital Equip, Laser, Refractive Correction, Ophthalmology – Rochester, NY

Clerio Vision Secures Patent for “Enhanced LIRIC” Vision Correction Design

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.