Panel Votes Against Medtronic’s Chronicle, Offers Ideas For New Trial
This article was originally published in The Gray Sheet
Executive Summary
FDA's Circulatory System Devices Panel offered Medtronic advice on how to design a new trial for its Chronicle implantable hemodymanic monitor after voting against approval of the product's PMA
You may also be interested in...
CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
St. Jude Eyes Possible Acquisition Of Heart Failure Monitor Firm CardioMEMS
St. Jude Medical is placing a $60 million bet on wireless implantable heart failure monitor developer CardioMEMS and has acquired an exclusive option to own the entire company via a Sept. 7 agreement
St. Jude Eyes Possible Acquisition Of Heart Failure Monitor Firm CardioMEMS
St. Jude Medical is placing a $60 million bet on wireless implantable heart failure monitor developer CardioMEMS and has acquired an exclusive option to own the entire company via a Sept. 7 agreement