| Dec 9, 2013
| 9:01 AM
(Reuters) - U.S. Food and Drug Administration staff reviewing data on Boston Scientific Corp's novel anti-stroke device highlighted the implant's failure to meet a key goal for effectiveness in a recent study but said on Monday that other data must be weighed in deciding whether it should be approved.
| Dec 9, 2013
| 7:26 AM
Dec 9 (Reuters) - Boston Scientific Corp's
anti-stroke device did not meet one measure of success in a
clinical study of the implant, but other data must be considered
when determining overall safety and effectiveness, staff members
of the U.S. Food...
| Nov 27, 2013
| 2:01 PM
By Bill Berkrot
Nov 27 (Reuters) - Researchers have found a higher rate of
dangerous blood clots forming in patients who received Thoratec
Corp's HeartMate II heart pump than had been seen in clinical
trials or prior experience, according to a study...
| Nov 25, 2013
| 5:23 PM
The Food & Drug Administration, citing concerns about the expanding scope of genetic tests and their marketing, has told the genomic testing company 23andMe it must stop marketing its in-home saliva collection kit and related genomic analysis service to...
| Nov 19, 2013
| 1:17 PM
By Ransdell Pierson and Bill Berkrot
Nov 19 (Reuters) - Gene analysis failed in a U.S. clinical
trial to help doctors select better doses of warfarin, the
widely used blood-thinner, which can cause dangerous bleeding if
doses are too high and fail to...