FDA to verify National Evaluating System for health technology with 12 test cases

Written by Ilana Landau, Editor

AventaMed (Cork, Ireland) has been announced as one of 12 real-world evidence (RWE) test cases selected by the National Evaluation System for health Technology Coordinating Center (NESTcc; VA, USA).

The National Evaluation System for health Technology Coordinating Center (NESTcc; VA, USA) — a Medical Device Innovation Consortium (MDIC; VA, USA) initiative — recently announced 12 new test cases for leveraging real-world evidence (RWE) and addressing priorities for medical device stakeholders. AventaMed (Cork, Ireland) was selected to be amongst this test case cohort.

The aim of these test cases is to accelerate the progress of NESTcc by helping to generate a RWE database that hope to improves product safety, the rate of patients access to these products and ultimately patients’ welfare.  

AventaMed — a pioneering organization in the field of ear, nose and throat surgical devices — is the first, and only, Irish company to be selected for inclusion as a test case. AventaMed’s novel device offers an alternative to conventional ear tube surgery by allowing insertion of ear tubes without the use of general anesthesia.

Rachael Fleurence, Executive Director of NESTcc, commented that the 12 projects “…constitute an exciting and diverse portfolio that tests the capabilities of NESTcc’s Data Network in pre-market and postmarket settings and complements the projects selected in the initial round in 2018,”

Jeff Shuren, MDIC Board Member and Director of the FDA’s Center for Devices and Radiological Health (VA, USA), stated: “As part of ongoing efforts to modernize our approach to device safety, the FDA is striving to meet an important and aggressive goal that we set for ourselves: ensuring that the agency is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

Shuren continued: “These new test cases help show the potential for NEST to help reach the goal of systematically using real-world data to enable the efficient development of new, innovative medical devices and rapidly identify and address safety signals in a postmarket setting to keep patients safe.”

Olive O’Driscoll, Chief Executive of Aventamed, commented: “It is a great honor to be selected, as the only Irish company and we are very proud to be recognized and positioned alongside leaders in the medtech arena. This is a unique opportunity for a small start up to collaborate with renowned experts at leading healthcare organizations in the USA.”

O’Driscoll continued that the collaboration “…will enable us to acquire and investigate this data which would not ordinarily be available to medical device companies to inform our strategic and commercial decisions as we enter this important new market.”