NxStage Dialysis Needle Technology Gets FDA Nod
This article was originally published in The Gray Sheet
The company says its new needle technology means patients will only need to be pricked once during a dialysis procedure instead of twice which will reduce their discomfort while preserving vascular access.
You may also be interested in...
Teleflex buys Vidacare Corp. for $262.5 million. Integra LifeSciences acquires Covidien’s Confluent Surgical product line, including the DuraSeal products, for $235 million, plus up to $30 million in milestone payments. W.L. Gore ordered to pay more than $850 million to C.R. Bard to partially resolve a long-running patent dispute. More news.
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.
Trade group offers timeline for shift in FDA thinking about the amino acid commonly used in supplements in complaint seeking to block agency from preventing sales of NAC-containing supplements. Complaint also attests that, unlike its current stance, FDA in 1993 acknowledged NAC is lawful for use as a dietary ingredient.