MedTech Startup Roundup – Vol.1 No.29

The news you need on MedTech startups

Dan’s Picks

TruLeaf Medical: Implant, “Needle Stick” Heart Valve, Interventional Cardiology – Caesarea, Israe

Allmed Solutions Achieves Landmark ‘Needle-Stick’ Heart Valve Replacement

Neuralink: Implant, BCI, Neurology – Fremont, CA

Elon Musk’s Neuralink taps FDA regulator who led division overseeing the startup

Cytovale: Diagnostic, Rapid Test, Sepsis – San Francisco, CA

Rapid Sepsis Test Enables Hospital to Reduce Mortality by 42% and Shorten Hospital Stay by Two Days, According to Academic Medical Center Study

Flow Neuroscience: DME, Stimulation, Depression, Mental Health – Malmö, Sweden

U.S. Approves First Device to Treat Depression with Brain Stimulation at Home

Roivios: Procedural Device, Equipment, Renal Assist Device, Nephrology, Interventional Radiology – Nassau, Bahamas

Roivios Reports Promising Results from First-in-Human Trial of JuxtaFlow® Renal Assist Device

Product Launches

Artera: AI, Diagnostic, Prostate Cancer Treatment – Los Altos, CA

Artera Debuts ArteraAI Prostate Test (Post‑RP), Expanding its Oncology Portfolio

MedINT Medical Intelligence: AI, Soft/SaaS, Clinical Decision Support – Tel Aviv, Israel

MedINT Launches First Human-in-the-Loop Medical AI Platform for Complex Clinical Decision-Making

Kontakt.io : AI, Soft/SaaS, Pt. Care Operations – New York, NY

Kontakt.io Introduces Access Agent to Boost Outpatient Clinic Efficiency By Up To 20% With AI

Rula: AI, Soft/SaaS, Scribe – Los Angeles, CA

Rula Launches Clinically-Guided AI Note-Taking to Streamline Documentation and Improve Access to Care

Oncobit: Diagnostic, Precision Medicine, Oncology, Dermatology – Schlieren, Switzerland

TrilliumBiO and Oncobit Partner to Bring Novel Uveal Melanoma Monitoring Solution to the U.S.

eClinical Solutions: AI, Agents, Soft/SaaS, Analytics – Mansfield, MA

eClinical Solutions Unveils AI Agents to Power the Next Era of Clinical Data Automation

Xtant Medical: Implant, Spine Surgery, Orthobiologics, Biologics, Wound Care – Belgrade, MT

Xtant Medical Announces Commercial Launch of its Next-Generation nanOss Strata™ Synthetic Bone Graft

M&A

Acquisition
Neem: Soft/SaaS, Practice Mgt, Dental – New York, NY
Dandy: AI, 3D Printing, Dental Lab – New York, NY

Dandy Acquires Neem to Accelerate Digital Innovation in Dentistry

The Cs

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

Darius Shahida – CSO – Strategy (Joining)

Science Corporation Names Darius Shahida as Chief Strategy Officer

HealthTrackRx: Diagnostic, Molecular, Infectious Disease – Denton, TX

Harriss Currie – CFO (Joining)

HealthTrack Appoints Harriss Currie as Chief Financial Officer

Board Members

INBRAIN Neuroelectronics: Implant, BCI, Neurosurgery, Neurology – Barcelona, Spain

Scott Huennekens – Chairman of the Board (Joining)

INBRAIN Neuroelectronics Appoints Scott Huennekens as Chairman of the Board

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

Anthony Pagano – Board Member (Joining)

BillionToOne Appoints Anthony Pagano to Board of Directors as Audit Committee Chair

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

Rob ten Hoedt – Chairman of the Board (Joining)

Berlin Heals Welcomes Rob ten Hoedt as New Chairman of the Board

CathVision: Software/SaaS, Workflow, E-P Lab – Copenhagen, Denmark

Eric Thepaut – Chairman of the Board (Joining)

CathVision Announces Appointment of Eric Thepaut as Independent Chairman of the Board and Releases ECGenius® System Version 3.5

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

Sean Salmon – Board Member (Joining)

Adagio Medical Appoints Industry Veteran Sean Salmon to Board of Directors

Funding

Lin Health: Digital Medicine, Pain – Denver, CO

Lin Health Raises $11 Million Series A to Fuel Growth of Virtual Chronic Pain Recovery Platform

Simuhealth: Soft/SaaS, ERP, Public Health – Vancouver, BC

Simuhealth Raises $2.6M to Modernize Healthcare Training

AngelEye Health: AI, Soft/SaaS, Care Coordination, NICU, Neonatal, Pediatric – Nashville, TN

AngelEye Health Secures Additional $9 Million to Accelerate Innovation in Neonatal and Pediatric Care

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

Perimeter Medical Imaging AI Closes C$3.6 Million Non-Brokered Private Placement

a2z Radiology AI: AI, Soft/SaaS, Image Analysis, CT, Abdomen/Pelvis Triage – Boston, MA

a2z Radiology AI Raises $4.5M Seed Round to Scale Comprehensive CT Interpretation

BrainCheck: AI, Soft/SaaS, Diagnostic, Cognitive Function – Austin, TX

BrainCheck Awarded $500K NIH SBIR Phase I Grant to Advance eConsult Platform for Cognitive Care

Subsense: BCI, Non-Surgical, Neurology – Covina, CA

Subsense Expands Financing to $27 Million to Accelerate R&D for Non-Surgical Brain-Computer Interfaces

RoddyMedical: Device, Pt. Safety, Pt. Mobility, I-V – Wauwatosa, WI

NURSE CAPITAL INVESTS IN MEDICAL DEVICE STARTUP DEVELOPING NURSE-LED INNOVATIONS IN PATIENT CARE

Ritten: Soft/SaaS, EMR, Mental Health – Philadelphia, PA

Ritten raises $35m to expedite growth across behavioural health sector

Vicarious Surgical: Robotics, Surgical – Waltham, MA

Vicarious Surgical (NYSE: RBOT) sets up $100M shelf, $3M ATM program

Regulatory

Submittal
SS Innovations: Robotics, Telesurgery, Cardiac Surgery, Bariatric Surgery – Gurugram, India

SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System

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

Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

IDE
EyeYon Medical: Implant, Corneal, Artificial, Ophthalmic Surgery – Ness Ziona, Israel

EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt®, the First Artificial Endothelial Layer for Corneal Edema

Approval
ProVerum: Implant, Stent, BPH, Urology – Dublin, Ireland

FDA Approves the ProVee System – the First of a New Generation of Prostatic Urethral Stents for Treatment of BPH

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

Airiver Medical Secures IDE Approval from the FDA for Pivotal Clinical Study of the Airiver Drug Coated Balloon for Patients with Chronic Rhinosinusitis

Approval
MMI – Medical Microinstrument: Robotics, Microsurgery – Pisa, Italy

MMI Wins FDA Clearance and Completes First U.S. Clinical Use of Robotic Microsurgical Dissection Instruments with Symani

Approval
HeartBeam: DME, ECG, Wireless – Santa Clara, CA

HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment

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

Vektor Medical Receives FDA 510(k) Clearance Adding Atrial Flutter Mapping, Enhanced Connectivity and New Integration Capabilities to Next-Generation vMap

Approval
Bendit: Procedural Device, Micro-Catheter, Neurovascular, Interventional Oncology, Interventional Cardiology – Petah Tikva, Israel

Bendit Announces FDA Clearance for the Bendit17™ Steerable Microcatheter

Approval
Neurovalens: Digital Therapeutics, Neurostimulation – Belfast, Northern Ireland

Neurovalens granted FDA medical approval for weight management device

Approval
Vesalio: Procedural Device, Thrombectomy Catheter, Peripheral Vascular, Neurovascular – Plano, TX

Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology

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

FDA Approves the Zenflow Spring® Implant and Delivery System for First-Line Interventional Therapy of Patients with Benign Prostatic Hyperplasia (BPH)

Approval
Flow Neuroscience: DME, Stimulation, Depression, Mental Health – Malmö, Sweden

U.S. Approves First Device to Treat Depression with Brain Stimulation at Home

IDE
P&F: Implant, Transcatheter Heart Valve, Interventional Cardiology – Vienna, Austri

P&F secures FDA approval for TRICAV II pivotal clinical trial for severe tricuspid regurgitation

Product News

Providence Medical Technology: Implant, Spine, Spine Surgery – Pleasanton, CA

Providence Medical Technology, Inc. Announces Compatibility of CORUS-GLX™ System with Globus Medical’s Excelsius™ Navigation System for Posterior Lumbar Fusion

Breakthrough Devices

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

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin

Clinical Trials/Studies

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

Rapid Medical™ Completes Enrollment in DISTALS Trial Evaluating TIGERTRIEVER 13™ for Distal Vessel Occlusions

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

Natera Highlights New Findings in Lymphoma at the ASH Annual Meeting

SAGA Diagnostics: Diagnostic, Liquid Biopsy, Cancer – Morrisville, NC

SAGA Diagnostics’ Pathlight™ MRD Further Demonstrates Clinical Validity In TNBC Trials Presented at SABCS

TruLeaf Medical: Implant, “Needle Stick” Heart Valve, Interventional Cardiology – Caesarea, Israe

Allmed Solutions Achieves Landmark ‘Needle-Stick’ Heart Valve Replacement

Canopy: Soft/SaaS, Remote Monitoring, Therapeutics – New York, NY

Oral Presentation at ASH 2025 Shows Canopy RTM Cuts Infection-Related Hospitalizations by 52% and Generates Nearly $1M in Annual Savings per 1,000 Patients

OM1: AI, Precision Medicine, Decision Support, Orthopedic – Boston, MA

New Lancet-Published Study Shows AI-Powered Decision Support Tool Improves Decision Quality and Patient Outcomes

Nitinotes: Procedural Device, GI Surgery, Automated Suturing Platform – Caesarea, Israel

Nitinotes Announces First Patient Treated in Pivotal EASE™ Clinical Trial Evaluating the EndoZip™ Automated Suturing System for ESG

Cytovale: Diagnostic, Rapid Test, Sepsis – San Francisco, CA

Rapid Sepsis Test Enables Hospital to Reduce Mortality by 42% and Shorten Hospital Stay by Two Days, According to Academic Medical Center Study

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

New Publication Demonstrates the Importance of NeXT Personal Ultrasensitive Detection of Residual Disease in Lung Cancer

Roivios: Procedural Device, Equipment, Renal Assist Device, Nephrology, Interventional Radiology – Nassau, Bahamas

Roivios Reports Promising Results from First-in-Human Trial of JuxtaFlow® Renal Assist Device

Partnerships

Oncobit: Diagnostic, Precision Medicine, Oncology, Dermatology – Schlieren, Switzerland
TrilliumBiO: Diagnostic – Rockville, MD

TrilliumBiO and Oncobit Partner to Bring Novel Uveal Melanoma Monitoring Solution to the U.S.

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.