Medical Device News Magazine

A Digital Publication for the Practicing Medical Specialist, Industry Executive and Investor

Medical Device Industry News | Latest Developments, Breakthroughs & Future Outlook

Latest News

Halo340B Launches Innovative AI-Powered Platform to Strengthen 340B Compliance and Optimize Revenue for Healthcare Providers

By delivering a seamless, automated solution, Halo340B eliminates the complexities of program compliance while uncovering missed opportunities to significantly increase revenue for covered entities

May 12, 2026

HeartBeam Expands Commercial Presence Across Four Key U.S. Markets with Addition of Premier Concierge Practice

Leading concierge practice Atelier Health, led by physicians affiliated with Cedars-Sinai, will now offer HeartBeam to its patients. Opens up flagship sites across New York, Dallas, South Florida and Southern California, supporting scalable expansion of HeartBeam technology in preventive cardiology.

May 7, 2026

Microsure Announces CE Mark Approval and CEO Transition as Company Enters Next Phase of Clinical Growth

Alex Joseph will take on the role of Chief Executive Officer, succeeding Iwan van Vijfeijken.

May 7, 2026

TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health

Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare

May 1, 2026

Clinical Trials

Rapid Medical™’ Reports TIGERTRIEVER™ 13 Demonstrates Promising 90-Day Outcomes in DISTALS Trial, Reinforcing Pivotal Safety and Efficacy Findings

May 7, 2026

Full data presented at ESOC 2026 further strengthen the clinical evidence supporting TIGERTRIEVER™ 13 for the treatment of distal vessel occlusion stroke — a segment representing nearly half of all ischemic strokes

Breast Cancer Locator may transform breast surgery – new pivotal data | Reports Cairn Surgical

May 5, 2026

The technology is customized to each patient’s breast and tumor via 3D printing

Nectero Therapeutics Reports Two-Year Safety and Efficacy Data from First-in-Human Trial for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms

April 23, 2026

The results were presented at Charing Cross 2026 by Dr. Andrew Holden during a session on Abdominal Aortic Aneurysm (AAA) disease management

Biotechnology News

Mopec Group Introduces Cortex Systems to Advance Connected Pathology Workflows

This evolution formalizes Mopec Group's commitment to developing integrated, technology-driven solutions that enhance how pathology laboratories document, manage, and move through the diagnostic workflow

May 12, 2026

Lab Thread introduces Unified Lab Software Platform to streamline biological research

Connects scientific teams, data and workflows within a single, fully integrated digital lab management system

April 30, 2026

Building the Future of Biotechnology — UK Biotech Day 2026

UK Biotech Day 2026 is designed to spark meaningful conversations, high‑impact collaboration and actionable outcomes, and offers the attendees the opportunity to explore the latest trends across therapeutic innovation, manufacturing, healthtech integration, regulatory developments and investment dynamics.

April 27, 2026

Mergers & Acquisitions

Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies

Under the terms of the agreement, Lilly will acquire Kelonia, and Kelonia shareholders will receive up to $7.00 billion in cash, inclusive of an upfront payment of $3.25 billion, and subsequent payments upon achievement of certain clinical, regulatory and commercial milestones

April 20, 2026

Medtronic completes acquisition of CathWorks, expanding its leadership in transforming care for patients with cardiovascular disease

CathWorks FFRangio® System employs drug-free, wire-free technology for comprehensive physiological assessmen

April 20, 2026

Fertio Acquires Cascade Cryobank, Expanding Fertility Care and Donor Transparency

This strategic move unites Fertio’s 20+ years of global expertise with Cascade’s innovative early donor disclosure program, advancing fertility care and family-building options for U.S. parents

March 19, 2026

Medtronic to acquire Scientia Vascular, marrying access and therapeutic portfolios for neurovascular care

Deal complements Medtronic’s Neurovascular portfolio, delivering simplicity and access when ‘time is brain’

March 10, 2026

Funding

Vivatides Therapeutics Announces Oversubscribed $54 Million Series A Financing to Accelerate Extrahepatic RNA Therapeutics Development

April 10, 2026

Advancing next-generation RNA therapeutics beyond the liver through breakthrough delivery technologies

Earendil Labs Announces $787 Million in Financing to Scale AI-Driven Biologics Discovery and Development

March 20, 2026

The funding will accelerate Earendil Labs’ AI-driven R&D platform, expand its interdisciplinary teams, and advance a growing pipeline of antibody and biologics programs, with the goal of delivering first-in-class and best-in-class therapies for patients with serious diseases.

Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer

March 18, 2026

Financing co-led by Taiho Ventures and Arkin Bio Capital with significant participation from other new and existing investors

Thrombolex Secures $50M Series A Financing to Advance Endovascular Treatment for Pulmonary Embolism and Venous Thrombus

March 16, 2026

The financing significantly strengthens the company’s capital position as it expands U.S. commercial infrastructure and advances clinical evidence generation across its endovascular catheter platform.

Industry Expert Bylines

Timing Is Biology: Integrating Circadian Physiology into Nutritional Strategy By Katherine Klyushnichenko

May 11, 2026

Katherine Klyushnichenko
DiogeneAge, Inc. 1910 Thomes Avenue, Cheyenne, Wyoming 82001-3527, USA | kathy@diogeneage.com

Dr. Thomas Rhee’s Innovative Stem Cell Cream and the Future of Preventative Care

April 14, 2026

While many regenerative treatments rely on injections administered in specialized clinics, his cream is designed to offer a non-invasive alternative

Finding Common Regulatory Ground in AIs Growing Role within Pharmacovigilance | By: Anuradha (Annie) Prabhakar, Associate Director, Product Management, Vigilance Detect, IQVIA

April 8, 2026

Pharmacovigilance has traditionally required organizations to balance the urgency of reporting with the rigor of accurately detecting adverse event and product complaints. AI has the potential to ease this burden by enabling earlier pre‑signal identification, automated detection, faster case processing and expanded surveillance across both structured and unstructured data

FDA Medical Device Updates

Market Reports

TaeWoong Medical USA Receives FDA 510(k) Clearance for SPAXUS™, Expanding Its EUS Therapeutic Portfolio

The FDA determined the SPAXUS™ Stent to be substantially equivalent to legally marketed predicate devices, allowing for commercialization in the United States

May 1, 2026

Grifols Gets FDA Approval for Malaria Blood Screening Assay

The Procleix Plasmodium Assay aims to improve blood safety by detecting Plasmodium, a mosquito-borne parasite that causes malaria and is responsible for an estimated 282 million infections and 610,000 global deaths annually

April 16, 2026

Global Wound Care Market to Reach USD 30.48 Billion by 2030

April 30, 2026

GCC Medical Consumables Market to Reach USD 635.29 Million by 2032, Driven by Expanding Healthcare Infrastructure and Rising Surgical Demand

March 25, 2026

Executives

ACU-Serve Names Natasha Baria Mehta President to Lead Next Phase of Strategic Growth

Mehta brings 25+ years of healthcare Revenue Cycle Management experience with a proven track record of scaling complex operations, driving financial performance, implementing advanced technologies, and building high-performing teams

May 12, 2026

Eko Health Appoints Dr. Steven Steinhubl as Chief Medical Officer

As Chief Medical Officer, Dr. Steinhubl will help drive Eko’s clinical strategy, research initiatives, and external scientific collaborations, further strengthening the evidence base and accelerating AI adoption across health systems worldwide.

May 7, 2026

Stealth BioTherapeutics Appoints David A. Brown, Ph.D., as Chief Scientific Officer

Brown brings more than 20 years of experience in mitochondrial research and scientific team leadership.

April 8, 2026

SynerFuse® Announces VP of Strategy: Thomas T. Lee, M.D., FAANS, MBA

Dr. Lee is a renowned talent, in the fields of both neurosurgery and finance

April 2, 2026

Advancements In Imaging

Brainomix and Boehringer Ingelheim Advance Strategic Partnership in Pulmonary Fibrosis

Dr. Michalis Papadakis, CEO and Co-Founder of Brainomix said: “We are excited to expand our strategic partnership with Boehringer Ingelheim, a recognized leader and innovator in this field, with whom we share a firm commitment to improving outcomes for people living with pulmonary fibrosis.

May 12, 2026

Olympus Receives FDA Clearance for POWERSEAL™ Open Extended Jaw Device

Olympus Corporation, a global medical technology company committed to making people’s lives healthier, safer, and more fulfilling, announced today it has received FDA 510(k) clearance

April 28, 2026

Philips Secures FDA Clearance for Rembra Platform

Dan Xu, Business Leader of CT at Philips. “With the Rembra platform, we are redefining what clinicians can expect from CT, combining speed, scalability, and precision to expand access to high-quality imaging while supporting confident diagnosis and highly accurate treatment planning.”

April 22, 2026

Philips receives FDA 510(k) clearance for Verida

The world’s first AI-powered detector-based spectral CT*, advancing diagnostic precision across clinical applications

April 16, 2026

Hospitals In the News

Delray Medical Center First Hospital in Palm Beach County to Use Spiration™ Valve System and SeleCT™ Screening for the Treatment of Severe Emphysema

SeleCT Screening automatically reviews existing chest computed tomography (CT) scans to help identify patients who would benefit from bronchoscopic lung volume reduction (BLVR). BLVR with endobronchial valves such as the Spiration Valve System may improve lung function by allowing airflow to be redirected from hyperinflated portions of the lung to healthier portions

April 14, 2026

Chapters Health System Announces Selection on CHROs to Know List

Chief People Officer, Nikki Romence, has been named one of Becker’s Hospital Review’s “140 Hospital and Health System CHROs and Chief People Officers to Know” for 2026

March 19, 2026

Baptist Health, Compass Surgical Partners Advance Northeast Florida Surgery Network with Middleburg Surgery Center

Located in southeast Jacksonville near Baptist Medical Center Clay, the multispecialty ASC supports procedures in orthopedics, urology, otolaryngology, pain management, and general surgery. With 15 physician partners committed to the center, the partnership is evaluating expansion opportunities to meet growing demand.

March 10, 2026

First Multi Functional European Training in Augmented SBRT conducted in Monza

The clinic is currently conducting research into single-fraction treatment, where therapy is delivered in one session (while traditional radiotherapy requires 20–40 treatment sessions)

March 10, 2026

Non-Profit News

Health Leaders Join Forces to Launch First-of-Its-Kind Women’s Health AI Consortium

Industry leaders from across the health ecosystem, including Clue, Ema EQ, Thrive Global, Oura, and Willow, will set the first clinically rigorous, transparent standards for AI in women’s health

May 12, 2026

AMDR | Hospitals and Surgical Centers Saved Record $495M (€421M), Eliminated the Need for 6.3 Million Gallons of Gasoline, by Using Reprocessed “Single-Use” Medical Devices from AMDR Members in 2025

New Industry Research Shows Record 11,458 Hospitals and Surgical Centers in 18 Countries Used Reprocessed Devices to Reduce Costs, Emissions Last Year

May 11, 2026

The Canadian Association of Optometrists celebrates Vision Health Month with online campaign encouraging Canadians to “GetEyeWise”

As the national voice of optometry, CAO remains committed to using Vision Health Month to raise awareness about the importance of regular, comprehensive eye exams

May 1, 2026

Blast Exposure Linked to Brain Aneurysms in U.S. Special Operations Forces

For the study, 564 U.S. Special Operations Forces personnel (mean age 43 years, 563 men) were evaluated in the Comprehensive Brain Health and Trauma Program.

April 14, 2026