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Finger prick lab tests, Theranos
October 28, 2015
Finger prick lab tests, Theranos

FDA Says Theranos Device Uncleared, Finds Host of Problems

By Maria Fontanazza

Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.

Continue reading →

October 26, 2015

2015 Update on the Diabetes Market In Asia

By Ames Gross

As the incidence of diabetes across Asia expands, demand for medical devices and drugs to treat the disease is intensifying.

Continue reading →

Maria Fontanazza and Ian Strickland discuss future of medtech market at AdvaMed 2015
October 15, 2015
Maria Fontanazza and Ian Strickland discuss future of medtech market at AdvaMed 2015

MedTech Market to Hit $470 Billion by 2020, Prepare for Consolidation

By MedTech Intelligence Staff

Expect to see slow growth and more mergers & acquisitions.

Continue reading →

John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015
October 14, 2015
John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015

2015 MedTech Highlights: Low Industry Growth, VC Declines, M&A Impressive

By MedTech Intelligence Staff

Ernst & Young’s Pulse of the Industry report is out, and once again, it’s not all gloom and doom.

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Nicole Littman, Quorum Consulting
October 8, 2015
Nicole Littman, Quorum Consulting
Soapbox

CMS Reveals Rationale for NTAP Decisions in Rule Making

By Nicole Littmann

What can we learn about how new technologies become eligible for additional payment?

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Pediatric technologies
October 8, 2015
Pediatric technologies

MedTech Designers: Children Are Not Small Adults

By Maria Fontanazza

There is a great unmet need for pediatric-specific devices. Why aren’t more manufacturers addressing this critical area?

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October 7, 2015
Ameing for Asia

Key Regulatory Issues for Establishing New Green Field Device Factory in China

By Ames Gross

Remember, several basic regulatory approvals are required.

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MobileODT, Clinician uses device
October 1, 2015
MobileODT, Clinician uses device

Mobile Technology Ready to Change Standard of Care in Cervical Cancer Detection

By Maria Fontanazza

The technology platform has already gone global and has the potential to be a true breakthrough in screening and detecting several types of cancer.

Continue reading →

Medical devices market in Russia, Intertek
September 29, 2015
Medical devices market in Russia, Intertek

Regulatory Changes and Market Access for Medical Devices in Russia

By Mark Miska

When entering this emerging market, the benefits may outweigh any risks.

Continue reading →

Japanese market, MedTech Intelligence
September 21, 2015
Japanese market, MedTech Intelligence

How to Succeed in Japan’s Medical Device Market

By Ames Gross

After preparing for three key issues, follow these recommended strategies when pursuing the market in Japan.

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Columns

August 10, 2026

What 524B and QMSR Change About Medical Device Risk

Balancing Cyber Risk

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

August 10, 2026

Why Few MedTech Sales Teams Are Using AI Where It Matters Most

By Lee Smith

A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed?

June 22, 2026

CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards Lifesciences

By MedTech Intelligence Staff

CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could significantly increase TAVR adoption, creating a growth opportunity for Edwards Lifesciences through expanded eligibility, higher procedure volumes, and continued leadership in structural heart care.

June 8, 2026

Medtronic Advances Hugo Robotic Surgery Platform with Key FDA Filings and Product Approvals

By MedTech Intelligence Staff
Medtronic Logo

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS instrument, alongside FDA clearance for its ProGrip™ Advanced hernia mesh. The developments expand the company's robotic surgery portfolio and support its growth strategy in minimally invasive surgical care.

June 8, 2026

Medtronic Posts Strongest Revenue Growth in a Decade, Driven by Cardiovascular and Surgical Businesses

By MedTech Intelligence Staff
Medtronic Logo

Medtronic reported robust fiscal 2026 results, fueled by strong growth in cardiovascular, medical surgical, and diabetes technologies, while advancing key product launches, regulatory milestones, and strategic acquisitions.

June 8, 2026

Boston Scientific Plans Indiana Distribution Center, 300 New Jobs

Boston Scientific

Boston Scientific will invest $138 million to build a 500,000-square-foot global medical device distribution facility in Plainfield, Indiana, creating up to 300 high-wage jobs and expanding the state's growing life sciences sector.

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 20, 2026

The failure of the ‘usual suspects’ approach to life science recruitment

By Ivor Campbell

How has AI impacted the way in which companies recruit for senior specialists, particularly in highly niche roles in MedTech, biotech and pharmaceutical development? Finding the right people for these roles has never been harder.

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  • MedTech Economics
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