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The Connected Worker Is Key to Meeting COVID-Related Manufacturing Demands

Apr 19, 2021

Virta Health Raises $133M to Reverse Type 2 Diabetes

Apr 19, 2021

12 Recently-Approved Medical Devices

Apr 19, 2021

Rapid COVID-19 Tests Are Coming to the Home

Apr 19, 2021

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Medtech in a Minute: Big Deals Keep on Coming

Apr 19, 2021

Virtual Surgical to Go Public Through Merger with D8 Holdings

Apr 16, 2021

Medtronic Grapples with Even More HeartWare Problems

Apr 16, 2021

Aran Biomedical Expands Contract Manufacturing in Galway and More Supplier News

Apr 16, 2021

Webinar Series: What's Next for Medtech Miniaturization?

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

Highlights

Understanding Regulatory Expectations for Combination Products

Apr 15, 2021

Experts from WuXi AppTec Medical Device Testing answer a few questions about submitting combination products for regulatory approval.

One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Apr 15, 2021

Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the...

Medtech in a Minute: FTC Crosses Swords with Illumina, Hologic's Shopping Spree Continues, and More

Apr 09, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

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Back to Basics: FDA to Host Workshop for Device Industry

Apr 07, 2021

Need to brush up on your regulatory knowledge? FDA will host a free workshop April 13 on two topics related to the CDRH Standards and Conformity Assessment Program.

J&J’s New Lenses Break the Limit for Traditional Contact Use

Mar 24, 2021

The Brunswick, N.J.-based company has won approval from the Japanese Ministry of Health, Labour and Welfare for a contact lens that provides vision correction and Ketotifen, an antihistamine drug to help relieve symptoms for people experiencing...

A Major Turning Point for COVID-19-Related Diagnostics

Mar 18, 2021

FDA granted marketing authorization to the BioFire SARS-CoV-2 test using the de novo pathway.

Developing Artificial Intelligence for Medical Devices

Mar 17, 2021

The use of artificial intelligence in medical devices is on the rise. Although there is no specific directive or regulatory framework yet, AI decisions still need to be understandable and verifiable to ensure patient safety. TÜV SÜD shares key...

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...

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 quality system...

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 system...

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.

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