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NGS Assays: Here are the Variables of Clinical Performance

Originally published Sept 8, 2023
By Sarah McLeod, M.S., Regulatory Analyst/Medical Writer

Next-generation sequencing (NGS) assays provide a clinically valid resource for precision medicine. Knowing how NGS assays perform on different regions of a chromosome with different genetic variants helps to determine the benefit of these tests for specific patient groups. This article offers a bulleted list of clinical performance evaluators by which to analyze published clinical trials. Get the article here.

Pediatric Medical Devices – Confronting Innovation Challenges

Originally published August 11, 2023
By Helga Weires, Nerac Analyst

Pediatric medical devices are critical for proper medical care of children.

This article explores some of the potential hurdles in the development and approval of pediatric medical devices. Get the article here.

AI – AI – Oh My!

Originally published July 5, 2023
By Rosemarie Szostak, Ph.D.

This article explores AI and the some of the potential applications, implications and costs for unprepared industry. Get the article here.

Similar Devices in State of the Art

Originally Published May 4, 2023
By Priscilla S. Monarca, M.P.H.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Get the article here.

Digital Transformation – How to Do it Right

Originally Published April 18, 2023
By Dr. Ripi Singh, Dr. Johannes Vrana, Inspiring Next

A large fraction of Digital Transformation efforts fail to deliver their promised value. This article helps to demystify Digital Transformation and build an executable roadmap. Get the article here.

The Road to IVDR Implementation

Originally Published March 20, 2023
By Sarah McLeod, M.S.

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. This article takes a closer look at the revised implementation timeline and potential impacts on certification. Get the article here.