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FDA
February 4, 2019
FDA

Recent FDA Action: Three Recalls and Ten Medical Device Approvals

By MedTech Intelligence Staff

The device approvals address critical patient need.

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Charlie Kim, Soom
February 1, 2019
Charlie Kim, Soom
Soapbox

Keep Calm and Carry On… And Other Outlooks We Can Apply to MDR Implementation

By Charlie Kim

With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.

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FDA
January 29, 2019
FDA

2018 a Record Year for Approval of Novel Medical Devices

By MedTech Intelligence Staff

Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.

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FDA
January 18, 2019
FDA

FDA Investigating Long-Term Mortality Related to Paclitaxel-Coated Balloons and Stents

By MedTech Intelligence Staff

The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.

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MedTech Intelligence
December 31, 2018
MedTech Intelligence

Advanced CAPA Conference Digs Deep into Challenges and Root Cause Analysis

By MedTech Intelligence Staff

This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.

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magnifying glass
December 27, 2018
magnifying glass

Best of 2018 in MedTech

By MedTech Intelligence Staff

Here are the most read articles of the year.

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Patrick Parks, 3M
December 26, 2018
Patrick Parks, 3M
MEDdesign

The State of Skin

By Patrick J. Parks, M.D. Ph.D.

It’s the body’s first line of defense, and this important organ should not be an afterthought.

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Brian Ochs, 3M Medical Materials and Technologies
December 12, 2018
Brian Ochs, 3M Medical Materials and Technologies
MEDdesign

Five Stages to Bringing a New Medical Device to Life

By Brian Ochs

While the road to bringing a medical device to market is often bumpy, working with an experienced and knowledgeable partner can help navigate the process and potentially avoid some of the bumps.

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European Union Flag
December 10, 2018
European Union Flag

First Step in EU MDR Compliance: The Gap Analysis

By Maria Fontanazza

A gap assessment provides a toolbox for the decision-making process.

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European Union Flag
November 29, 2018
European Union Flag

Misconceptions of EU MDR Implementation

By Maria Fontanazza

Lack of preparation and understanding of the efforts required to comply with the regulation will hinder product launches, negatively impact sales, and hurt a company’s reputation.

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Columns

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

September 2, 2025

Impact of Combination Products on the Medical Devices Industry

By Partha Anbil
combination devices

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.

August 26, 2025

Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)

By Celegence
combination products

Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.

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.

TOPICS

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

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