FDAnews Device Daily Bulletin

A recent Government Accountability Office (GAO) report on healthcare fraud shows a high prevalence of fraud and abuse in the durable medical equipment (DME) sector.

China’s proposed update to good clinical practice requirements for medical devices includes tougher provisions on ethics committees and human subject protections.

Data uncovered by EDCUtah Researcher Brigham Mellor shows that Utah leads the nation in its concentration of medical device manufacturing firms and also in its employment of medical device engineers and medical appliance technicians.

The State Food and Drug Administration, China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013.

NxStage Medical, a leading manufacturer of innovative dialysis products, officially opened its new headquarters in Lawrence, Mass.

As the western European markets throw up opportunities for polymer-based medical devices, Gujarat, India-based players are gearing up to export to the EU nations.

Cambridge Consultants has been selected by device pioneer HemoSonics to finalize the development of its new diagnostic instrument.

An analysis conducted by PricewaterhouseCoopers shows overall implantable device operating profit declined from 2010-2011, suggesting the industry segment may no longer be king in the medical device market.