MedTech Startup Roundup – Vol.1 No.12

The news you need on MedTech startups

Dan’s Picks

XRHealth: XR, Physical Therapy, Cognitive Therapy – Needham, MA

XRHealth Launches Unified Platform XRHealth 2.0 – The World’s Largest Unified XR Therapeutic Ecosystem

Teal Health: Diagnostic, Remote Testing, Gynecology, Cervical Cancer – San Francisco, CA

Following FDA Announcement, Teal Health’s Teal Wand™ for At-Home Cervical Cancer Screening is Now Available, Starting in California

Product Launches

Catalyst OrthoScience: Implant, Orthopedic, Shoulder – Naples, FL

Catalyst OrthoScience Announces Full Commercial Release of Fracture Shoulder System

HealthEx : Soft/SaaS, Pt. Access to Medical Records – San Francisco, CA

HealthEx Launches Platform to Empower Patients with Real-time Health Record Access in Collaboration with Industry Leaders

XRHealth: XR, Physical Therapy, Cognitive Therapy – Needham, MA

XRHealth Launches Unified Platform XRHealth 2.0 – The World’s Largest Unified XR Therapeutic Ecosystem

Teal Health: Diagnostic, Remote Testing, Gynecology, Cervical Cancer – San Francisco, CA

Following FDA Announcement, Teal Health’s Teal Wand™ for At-Home Cervical Cancer Screening is Now Available, Starting in California

Wenzel Spine: Implant, Spine Surgery – Austin, TX

Wenzel Spine Announces Limited U.S. Commercial Launch and First Cases of its Expandable panaSIa™ SI Fusion System

GoMo Health: Digital Therapeutics, Multi-Specialty – Asbury Park, NJ

GoMo Health Launches the Women, Children and Families Engagement Hub to Improve Whole-Family Care and Health Outcomes In Every Life Stage

The Cs

Cardiosense: AI, Diagnostic, Cardiology – Chicago, IL

John Martin, MD – CMO – Medical (Joining)

Cardiosense Appoints Medtech Executive John Martin, MD as EVP and Chief Medical Officer

Minze Health: Digital Diagnostic, Digital Therapeutic, Urology – Antwerp, Belgium

Tom Moore – CEO (Joining)

Minze Health Appoints Thomas Moore as President and Chief Executive Officer

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

Ajit Singh – CEO (Joining)

Ajit Singh Appointed CEO of Harbinger Health and CEO-Partner of Flagship Pioneering

Canary Speech: AI, Soft/SaaS, Clinical Decision Support, Voice Biomarkers – Provo, UT

Dr. Kang Hsu, Jr. – CMO – Medical (Joining)

Canary Speech Appoints Dr. Kang Hsu, Jr. as Chief Medical Officer to Lead Clinical Strategy and Expand Voice Biomarker Adoption

Synergy Spine Solutions: Implant, Spine – Louisville, CO

Troy Wahlenmaier – CCO (Joining)

Synergy Spine Solutions Appoints Troy Wahlenmaier as Chief Commercial Officer

Funding

Amalgam Rx: AI, Soft/SaaS, EHR, Clinical Decision Support – Wilmington, DE

Amalgam Rx Secures $20M Credit Investment from Catalio Capital Management to Accelerate Medical-Grade AI™ Deployment

Conformal Medical: Procedural Device, Left Atrial Appendage, Cardiology – Nashua, NH

Conformal Medical Closes $32 Million Series D Extension to Advance its Next-Generation Left Atrial Appendage Occlusion Technology

Arintra: AI, Soft/SaaS, Coding – Austin, TX

Arintra Raises $21M Series A to Expand Beyond Autonomous Medical Coding and Build the Future of Healthcare Revenue Assurance

Reprieve Cardiovascular: Capital Equip, ADHF Fluid Mgt, Cardiology – Milford, MA

Reprieve Cardiovascular Secures $61 Million Financing and Enrolls First Patient in Pivotal Study

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

bioAffinity Technologies Announces Pricing of Private Placement and Warrant Inducement Transaction for Approximately $1.2 Million in Gross Proceeds

RIVANNA: AI, Imaging, Ultrasound, Soft/SaaS, Anesthesia – Charlottesville, VA

RIVANNA secures $800,000 Virginia Catalyst Grant alongside matching funds to advance AI-enabled ultrasound platform for neuraxial anesthesia

Regulatory

Approval
Nyxoah: Neuromodulation, Sleep Apnea – Mont-Saint-Guibert, Belgium

Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea

Approval
Sonic Incytes: AI, Diagnostic Imaging, Ultrasound, Hepatology – Vancouver, BC

FDA Grants 510(k) Clearance for Sonic Incytes’ Velacur ONE™, AI-Guided Point of Care Ultrasound for the Management of Chronic Liver Diseases

IDE
Myra Vision: Procedural Device, Ophthalmic Surgery, Glaucoma – Campbell, CA

Myra Vision Secures FDA Approval to Initiate US IDE Study in Glaucoma

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

Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care

Approval
DeepSight Technology: Diagnostic Imaging, Ultrasound for Ultrasound Guided Devices – Santa Clara, CA

DeepSight™ Technology Receives First FDA 510(k) Clearance for NeedleVue™ LC1 Ultrasound System

Approval
SafeHeal: Procedural Device, Colorectal Surgery, Anastomosis Protection – Paris, France

SafeHeal® Receives European Marketing Approval Under MDR for Colovac® Anastomosis Protection Technology

Product News

Body Vision Medical: AI, 3D-Imaging, Oncology, Surgery – Weston, MA

Body Vision Medical Expands Access to AI Tomo® with Major LungVision® Platform Upgrade

PaceMate: Diagnostic, Remote Pt. Monitoring, Cardiology – Sarasota, FL

PaceMate Gains Exclusive Access to PaceArt Device Data Following Acquisition from Medtronic

Breakthrough Devices

Spinal Simplicity: Implant, Spine Surgery, SI Joint – Overland Park, KS

Spinal Simplicity Secures FDA Breakthrough Device Designation for IntraLink™

SpinaFX Medical: Procedural Device, Minimally Invasive, Spine, Spine Surgery – Toronto, ON

Triojection® from SpinaFX Granted Breakthrough Device Designation by U.S. FDA for Minimally Invasive Lumbar Disc Treatment

Reimbursement

Renata Medical: Procedural Device, Interventional Pediatric Cardiology – Newport Beach, CA

Renata Medical Announces CMS Approval of New Technology Add-On Payment (NTAP) for the Minima Stent System

Lungpacer Medical: Neurostimulation of Diaphragm, Breathing – Vancouver, BC

Lungpacer Announces CMS NTAP Approval for AeroPace® System in FY2026 IPPS Final Rule

Clinical Trials/Studies

ASR Systems: Procedural Device, Retractor, Trauma Surgery – San Antonio, TX

U.S. Military Study Identifies TITAN CSR® Retractor as Top Surgical Retractor for Deployed Trauma Care

Reprieve Cardiovascular: Capital Equip, ADHF Fluid Mgt, Cardiology – Milford, MA

Reprieve Cardiovascular Secures $61 Million Financing and Enrolls First Patient in Pivotal Study

Egg Medical: Radiation Protection, Surgical, Interventional

New Study Demonstrates Superiority of EggNest™ Complete Radiation Protection System in Comprehensive Protection for the Entire Interventional Team

Ultrasound AI: AI, Soft/SaaS, Birth Date Prediction, Women’s Health – Highlands Ranch, CO

Ultrasound AI Publishes Landmark Study Demonstrating Breakthrough in Predicting Delivery Timing Using AI and Ultrasound Images

Apreo Health: Procedural Device, Interventional Pulmonology – Menlo Park, CA

Apreo Health Announces First Patient Treated in BREATHE-3, Pivotal Clinical Trial of Company’s BREATHE Airway Scaffold

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

Landmark Clinical Study Published in Spine Demonstrates Superiority of Tissue-Sparing Circumferential Cervical Fusion Over ACDF Alone in Multilevel Cervical Fusion Surgery

Simpson Interventions: Procedural Device, Intravascular Imaging, Interventional Cardiology, Interventional Radiology – Campbell, CA

Simpson Interventions Announces First Patients Treated in Clinical Trial for its Acolyte™ Catheter System

Analytics 4 Life: AI, ML, Diagnostic, Multi-Disease Detection – Toronto, ON

Analytics For Life Completes Clinical Study of Non-Invasive Point-of-Care Test for Elevated Pulmonary Capillary Wedge Pressure (PCWP) Using Machine Learning

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

Orchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction

Galvanize Therapeutics: Procedural Device, PEF Ablation – Redwood City, CA

Galvanize Announces First Patient Enrolled in the PROPEL Registry Evaluating Aliya® Pulsed Electric Field Ablation for Soft Tissue Lesions

Legal Battles

Balt USA: Procedural Devices, Neurovascular, Interventional Cardiology, Interventional Radiology – Montmorency, France
Route 92 Medical: Procedural Device, Neurovascular – San Mateo, CA

Balt USA Responds to Patent Infringement Lawsuit Filed by Route 92 Medical

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.