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Market Access

August 3, 2015
Ameing for Asia

Finding Reliable Key Opinion Leaders in Asia Is Trickier Than You Think

By Ames Gross

Do your due diligence and make sure you have experienced, native boots on the ground.

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July 10, 2015
Ameing for Asia

Research Before Registration: Conducting Market Research in Asia

By Ames Gross

Before pursuing product registration in Asia, a thorough review of the market is essential.

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July 6, 2015
Reimbursement Report

Six Concepts to Navigate Manufacturer-Sponsored Clinical Trials

By Kristofer C. Munroe

What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.

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June 18, 2015
Reimbursement Report

Engaging ACOs: A How-To for Life Science Companies

By Marcia Guida James, MS, MBA, CPC

Successful accountable care organizations consist of a superior confluence of quality efforts, physician engagement, patient engagement, the right administration and the ability to keep costs down. The challenge comes in balancing these efforts while keeping costs to a minimum.

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June 17, 2015
Ameing for Asia

The Copycat Culture in China’s Medical Device Industry

By Ames Gross

There are several steps you can take to protect your IP and avoid medical device piracy in China.

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Rosemary Weghorst, Managing Director, Berkeley Research Group LLC
June 8, 2015
Rosemary Weghorst, Managing Director, Berkeley Research Group LLC

The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers

By Rosemary Weghorst

This year’s work plan includes several items that will impact medical device manufacturer and suppliers.

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Marcia Guida James, MS, MBA, CPC, is Vice President of Clinical integration and Accountable Care for Mercy Health System and Trinity Health
May 3, 2015
Marcia Guida James, MS, MBA, CPC, is Vice President of Clinical integration and Accountable Care for Mercy Health System and Trinity Health
Reimbursement Report

Understanding ACO Metrics for Success

By Marcia Guida James, MS, MBA, CPC

Success metrics in an accountable care organization (ACO) can be extensive in scope, from quality to cost to utilization to patient satisfaction—and all of these factors are important.

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May 2, 2015

Going Global: Should You Take the Leap?

By Brett Gopal

Before moving into the global market, a company needs to understand the local structure of geographic regions.

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April 15, 2015

J&J Sags in Medical Device, Still Plans to Launch 30 Products by 2016

By MedTech Intelligence Staff

Johnson & Johnson holds firm that it will continue to accelerate in the innovation department over the next year.

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April 15, 2015

Medtronic and IBM Partner to Transform Diabetes Management

By MedTech Intelligence Staff

IBM’s Watson Health Unit is forming several collaborations to facilitate personalized health on a massive scale.

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Columns

May 20, 2026

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Peter Justen is Founder and CEO of AmeriTrust Solutions. He works at the intersection of technology, data, and human-centered design to improve access to government...

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 announces strategic investment in MiRus LLC

By MedTech Intelligence Staff
Boston Scientific Logo

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

May 4, 2026

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

By MedTech Intelligence Staff
Medtronic

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

By MedTech Intelligence Staff
Sonire Therapeutics

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 Gains CE Mark for Stealth AXiS surgical system

Medtronic

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

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