A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
A color additive risk emulation tool named CHRIS (CHemical RISk calculator) has gained new Medical Device Development Tool (MDDT) designation through a voluntary program of the US Food and Drug Administration.
CHRIS is a non-clinical assessment model that helps medical device manufacturers address the biocompatibility of color additives in polymeric medical...
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
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.
