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Market Access

Featured Articles

May 19, 2026

Signatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive Bladder Cancer

By MedTech Intelligence Staff

Marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions and solidifies Natera’s Treatment on MRD (TOMR) approach for MIBC care.

May 19, 2026
Boston Scientific Logo

Boston Scientific announces strategic investment in MiRus LLC

By MedTech Intelligence Staff

Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy

May 4, 2026
Medtronic

Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

By MedTech Intelligence Staff

Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.

May 4, 2026
Sonire Therapeutics

Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

By MedTech Intelligence Staff

SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach

May 1, 2026

Johnson & Johnson Enters Agreement to Acquire Atraverse Medical

By MedTech Intelligence Staff

The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation business.

May 1, 2026

enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve

By MedTech Intelligence Staff

The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.

May 1, 2026
Medtronic

Medtronic Gains CE Mark for Stealth AXiS surgical system

Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.

May 1, 2026
Medtronic

Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition

By MedTech Intelligence Staff

CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment.

April 24, 2026

CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement

By MedTech Intelligence Staff

New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.

April 20, 2026
Stryker

Styker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude Acquisition

By MedTech Intelligence Staff

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio

View More Market Access Articles »

Columns

November 15, 2023
Soapbox

Unlocking Success in SaMD Product Launches Through AI

By Caroline Shleifer
Caroline Shleifer

AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.

September 20, 2023
Soapbox

The Power of AI to Enhance Clinical Trials

By John Schwope
John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

August 15, 2023
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom
Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

August 2, 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff
Supply Chain and Adv Mfg 2023

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

July 6, 2023
Soapbox

Managing the Post-Pandemic Pricing Squeeze

By Farida Ali
Farida Ali

As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.

Upcoming Events & Webinars

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On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?






Market Access Archive

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

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