In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc.
Listen to the podcast via the player below:
Medtech Insight article addressing topics discussed in this episode:
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.
Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
