Policy & Regulation

This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the government $5m for violating anti-kickback law; eCential Robotics’ spine platform made its debut for human use; and more.

A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven steps of the AI lifecycle.

Abbott has issued an urgent voluntary medical device correction for a small number of FreeStyle Libre 3 sensors distributed in the US during May. The sensors could give inaccurate readings, the company explained.

Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.