Regulatory & Quality

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.

FDA Outlines Plan for AI and Machine Learning-Based Software

Jan 13, 2021

The AI/ML Action Plan is a response to stakeholder feedback received from the April 2019 discussion paper.

New COVID-19 Variants Are Messing up Test Results, FDA Warns

Jan 08, 2021

Genetic variants of SARS-CoV-2, the virus the causes COVID-19, may lead to false negative results with molecular tests for the virus. So what is FDA doing about it?

These COVID-19 Tests Should Be Used with Caution

Jan 06, 2021

FDA has authorized over 300 COVID-19 tests and collection kits, but these tests are not all created equal. Here are the tests that have been flagged for potential false results.

Intellectual Property at the Intersection of Medical Devices and Artificial Intelligence

Jan 05, 2021

There are challenges to obtaining patents related to AI-based medical devices. What are your options?

Disruption in Medical Device and Diagnostic Manufacturing: 3 Lessons Learned

Dec 22, 2020

These takeaways from 2020 can help medical device and diagnostic industry manufacturers prepare for the next crisis.

Biggest Medtech Wins in 2020

Dec 18, 2020

As this incredibly challenging year finally comes to a close, we celebrate the medtech sectors, technologies, and trends that became the silver linings in 2020.

This Is a 'Genuine Breakthrough' in COVID-19 Testing

Dec 15, 2020

The chairman of the Senate health committee has dubbed a new low-cost, at-home, diagnostic a "genuine breakthrough" in COVID-19 testing.

Let's Talk Medtech: Diving into President-Elect Biden's Plan for Healthcare

Dec 04, 2020

PwC’s Health Research Institute has released its 2020 Election Report, which includes an analysis of how President-elect Joe Biden's term will impact the healthcare industry. Ben Isgur, leader of PwC's Health Research Institute, guest star's on...

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