FDAnews Device Daily Bulletin

The FDA Thursday ordered St. Jude Medical to conduct three-year postmarket surveillance studies of its troubled Riata and Riata ST coronary leads to obtain data on the likelihood of premature insulation failure.

Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies.

The FDA updated its reporting on its newly streamlined de novo medical device review pathway, detailing products the agency has cleared so far.

Microsemi announced a new die packaging technology has passed an internal qualification regime typical for active implantable medical devices consisting of thermal and mechanical stressing to MIL-STD-883 test standards.

A blood glucose monitor concept for diabetics that has a third of the environmental impact of traditional devices has been developed by UK tech design hothouse, Cambridge Consultants.

Real healthcare reform will require robust systems of health information exchange.

Vascular Solutions believes that it can make a real business out of a product line that St. Jude Medical discontinued in July 2011.

The National Institute for Health and Clinical Excellence in the UK is opening public comment on the use of Smith & Nephew’s Exogen bone-healing device.