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Medtronic, drug coated balloon, peripheral artery disease
December 16, 2015
Medtronic, drug coated balloon, peripheral artery disease

Medtronic Takes Manufacturing to Galway

By MedTech Intelligence Staff

The company will invest €13 million in the facility, which will make drug-coated balloons for peripheral artery disease.

Continue reading →

December 15, 2015

Transdermal Ibuprofen Patch to be Available in Two Years

By MedTech Intelligence Staff

Researchers say the technology enables a high drug load and consistent drug release profile.

Continue reading →

December 15, 2015
Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

Continue reading →

Combination product, drug, device and biologic
November 2, 2015
Combination product, drug, device and biologic

Two Key Processes You Must Know as a Combination Product Manufacturer

By David Amor

When preparing a regulatory submission, there are a couple of critical elements to consider.

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October 30, 2015
MEDdesign

Science Fiction Meets Nano-Robots

By Klaus Jopp

A peek at the latest miniaturization trends, including nano-robots that transport therapeutics to tumors.

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October 13, 2015

CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.

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Robert Califf, FDA
September 16, 2015
Robert Califf, FDA

President Obama Nominates Robert Califf as Next FDA Commissioner

By Maria Fontanazza

Industry doesn’t anticipate roadblocks from the Senate, expects confirmation.

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August 19, 2015

How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.

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August 3, 2015

What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.

Continue reading →

July 21, 2015

FDA: Developing Combination Products Requires Consistency, Transparency, Collaboration

By Maria Fontanazza

With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.

Continue reading →

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Columns

November 27, 2024

From design to disposal:
Reducing the footprint of single-use drug delivery devices

By Alex Fong
sustainable design

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman
LDT Development

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023

Instilling Trust in AI

Rama Chellappa

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

November 11, 2020
MEDdesign

Designing the Worst-Case Test to Get Best Case Results

By Dan Fowler
Dan Fowler, WuXi AppTec

To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.

November 4, 2020
Soapbox

How the COVID-19 Response Is Revealing Potential of IDMP

By Lise Stevens
Lise Stevens, Iperion

The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.

October 12, 2020

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza
Arlen Ward, System Insight Engineering

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff
Checkbox

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

August 4, 2020
Ameing for Asia

Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge

By Ames Gross
Ames Gross, Pacific Bridge Medical

In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.

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  • MedTech Economics
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Combination Products

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