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Market Access

Medtech, innovation
June 1, 2018
Medtech, innovation

FDA Launches Innovation Challenge to Fight Opioid Misuse and Abuse

By MedTech Intelligence Staff

CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.

Continue reading →

MedTech Intelligence
May 31, 2018
MedTech Intelligence

Five Most Popular Articles of 2018 (So Far)

By MedTech Intelligence Staff

Here’s a hint: Compliance with new regulation in Europe is a high priority.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
May 24, 2018
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Company Ignores FDA’s Request to Cease Commercial Distribution

By Dr. Christopher Joseph Devine

When FDA says stop, they mean stop!

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Liver
May 23, 2018
Liver

Liver Disease: A Growing Problem in Asia

By Ames Gross

Although pharmaceuticals are the main treatment route, medical devices are needed to fight the disease on a new level.

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Ames Gross, Pacific Bridge Medical
May 9, 2018
Ames Gross, Pacific Bridge Medical
Ameing for Asia

Diseases of the Kidney on Rise Across Asia

By Ames Gross

The need is growing for life-saving treatments.

Continue reading →

BSL2 laboratories, Starfish Medical, University of Victoria
May 1, 2018
BSL2 laboratories, Starfish Medical, University of Victoria

Rapidly Changing POC Assay Development Opportunity

By Nick Allan

In the quest for faster, more accurate results, these products will have a tremendous impact on diagnosing infectious diseases.

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magnifying glass
April 27, 2018
magnifying glass

Two New Accounting Standards Disrupting Medical Device Companies

By Dennis Howell, Jeffrey Ellis

Changes in financial reporting can be an annual disruption for medical device companies. But the impact of recent changes to financial accounting standards is likely the most sweeping since the passage of the Sarbanes Oxley Act of 2002.

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China
April 26, 2018
China

In Vitro Diagnostics Registration and Reimbursement in China

By Ames Gross

Access to the IVD market in China is lengthy and complicated.

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Footsteps
April 23, 2018
Footsteps

Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers

By Amy Scanlin

When applicable, the process provides novel products with a speedier route to market.

Continue reading →

Tal Rapke, Scalamed
April 17, 2018
Tal Rapke, Scalamed
Soapbox

Is Blockchain the Future of Digital Health?

By Tal Rapke, M.D.

No longer just the domain of bitcoin pundits and tech cowboys, blockchain technology has very real implications for the healthcare ecosystem—if we’re willing to give it a go.

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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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