Guidant has warned doctors of two separate failure modes that could occur in its Insignia and Nexus pacemakers. The alert came in response to one of the observations made by the FDA during its recent inspection of Guidant's St Paul, Minnesota facilities.
Guidant has warned doctors of two separate failure modes that could occur in its Insignia and Nexus pacemakers. The alert came in response to one of the observations made by the FDA during its recent inspection of Guidant's St Paul, Minnesota facilities.
According to Guidant, the failure modes could lead to a number of malfunctions, including loss of pacing output without warning;...
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 NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.
