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NuVasive Adds a Differentiated Option to the Product Bag with Simplify Deal

Feb 25, 2021

What the Minerva Supreme Court Decision Could Mean for the Medical Device World and Beyond

Feb 25, 2021

The Quest for an Earlier Diagnosis of Autism in Children

Feb 25, 2021

Medtronic Recalls Valiant Navion Due to Patient Safety Issue

Feb 25, 2021

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Virtual MD&M | BIOMEDigital Connects the Global Medtech and Biomedical Device Community

Feb 25, 2021

Overcoming Medtech Engineering Challenges

Feb 25, 2021

Who Is Winning in the Diabetes Management Market?

Feb 25, 2021

Could Bioelectronic Medicine Play a Role in Treating COVID-19 Symptoms?

Feb 24, 2021

Webinar Series: What's Next for Medtech Miniaturization?

Learn about the technological achievements that enable medtech miniaturization in this webinar series.

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FDA Lays Out Flaws Made in Initial Antibody Testing Guidance

Feb 17, 2021

FDA’s Jeff Shuren, MD, and Timothy Stenzel, MD, discussed the flaws of the antibody testing guidance in a recently published editorial in...

Why Risk-Based Thinking Is Essential in Medical Device Development

Feb 09, 2021

Many global regulatory requirements now include risk management, so medtech companies may need to revisit their...

When Software Becomes a Medical Device

Feb 08, 2021

As digitalization increases all around us, computer programs have also been making their way into our healthcare...

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Medtronic Wins Nod for Afib Treatment Device

Jan 29, 2021

The Dublin-based company inherited the DiamondTemp Ablation (DTA) system when it acquired Epix Therapeutics for $316 million in 2019.

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

Jan 24, 2021

FDA has added five tools to its catalog of regulatory science tools to help assess medical devices.

Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS

Jan 22, 2021

The Marlborough, MA-based company received CE mark for the Vercise Genus Deep Brain Stimulation (DBS) system in September of 2020.

Qiagen Resubmits EUA Application for QIAreach Antigen Test

Jan 21, 2021

In November of 2020, Qiagen decided to proactively withdraw the first emergency use authorization submission to address a chemistry-related issue.

Can Design Controls Accelerate Medical Innovation?

Nov 16, 2020

Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to...

Traceability Requirements in EU MDR

Nov 12, 2020

Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device...

Medtech Unfiltered - Affordable Care Act

Medtech Unfiltered: Should the Affordable Care Act be Struck Down?

Nov 10, 2020

News Editor Amanda Pedersen shares her thoughts on the Affordable Care Act as the U.S. Supreme Court hears oral arguments to...

Telehealth Considerations for Medical Device Manufacturers During and After COVID-19

Oct 20, 2020

A deep dive into how COVID-19 has forced many healthcare providers to adopt telehealth solutions, and some legal considerations for manufacturers.

Building a Better Supply Chain Through Unique Device Identification

Oct 20, 2020

Class I medical device companies have work to do, despite the UDI enforcement delay.

Before You Throw Out That FDA Guidance on Lab-Developed COVID Tests ...

Oct 15, 2020

Beware of the legal and reimbursement implications of not seeking FDA authorization for your lab-developed COVID test, legal experts warn.

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