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What are the 4 Essential Elements of Medical Device Design?

Oct 03, 2023

Removing the Pain from 'Just a Little Pinch' Gynecological Procedures

Oct 02, 2023

Changes to CFRs Will Focus on How Manufacturers Use Risk Management

Oct 02, 2023

Cordis Is Involved in M&A, But Not in the Way You Might Think

Oct 02, 2023

Medtech in a Minute: Edwards at the Center of Antitrust Accusations, and More

Oct 02, 2023

Philips Scandal Is a Blight on Medtech's Reputation

Oct 02, 2023

Additive Manufacturing Can Be a Superpower, If You Know How to Use It

Oct 02, 2023

Medtech Giants With the Midas Touch: Their Secrets to Success

Sep 29, 2023

U.S. Medtech Incubators and Accelerators

Check out these U.S. medtech incubators and accelerators organized by state.

Highlights

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

Sep 11, 2023

The draft for the next revision of ISO 10993-1 represents a complete overhaul, including many updates and a shift towards a more...

A Look at Updated Standards for Reusable Medical Devices

Sep 11, 2023

Nelson Laboratories delves into the impact of updated standards on IFU validations for reusable medical devices.

ISO Chemical Characterization for Medical Devices

Aug 10, 2023

By comprehensively evaluating the allowed limit of extractable chemical levels in medical devices, manufacturers...

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High-Quality (Level 4) PMCF Surveys: What Are They?

May 23, 2023

High-quality (level 4) PMCF surveys seem the go-to alternative to general usability (level 8) surveys. But are there cases where the latter approach is sufficient?

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Apr 19, 2023

Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved.

Picking A Semiconductor Aging Test Method

Apr 05, 2023

With multiple different options available for semiconductor aging testing, which is the right choice for your product? And, what do the tests entail?

FDA to Require Diversity Action Plan for Clinical Trials

Mar 06, 2023

Public Law 117-328 underscores existing FDA recommendations on improving clinical trial diversity.

COVID-19 Public Health Emergency Extended Amid Subvariant Spread

Jan 17, 2023

However, the declaration might soon be nearing its end, resulting in millions losing Medicaid coverage.

This Company Wants You to Pee on Its New Device

Jan 04, 2023

I promise this isn’t clickbait. Withings’ U-Scan wants to become the WebMD of your pee.

Understanding the Testing Behind Drug Delivery Devices

Nov 22, 2022

Katie Grayson, of EKG Labs, is set to speak about analytical considerations surrounding extractables and leachables testing of...

A Monkeypox PCR Test Is in the Works

Sep 30, 2022

The team responsible for the COVID-19 PCR test are in the process of adapting the platform for monkeypox.

Visby Puts PCR Testing in the Palm of a Patients Hand

Jun 30, 2022

The San Jose, CA-based company raised $135 million in an over-subscribed series E round and will use some of the proceeds to bring its portable infectious disease test to the home setting.

Test Electronics as Early as Possible

Jun 24, 2022

Early-stage electronics testing may help engineers transition designs to manufacturing much faster.

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