Regulatory and Compliance
Mar 26, 2015
Marie Thibault Olympus America Inc. today released its new, validated reprocessing procedures for its TJF-Q180V duodenoscope. The higher-level disinfection...
Mar 26, 2015
Marie Thibault Griping about FDA approval times has long been a favorite pastime of medical device executives, but if 2014 is any evidence, that complaint...
Mar 23, 2015
It is time for FDA to fulfill its primary mission of protecting public health and put patients first. Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD Over...
Mar 23, 2015
Marie Thibault   The Advanced Medical Technology Association (AdvaMed) has voiced its opinion on which topics the medtech industry believes should be...
Mar 20, 2015
Delving deeper on FDA’s final guidance for reprocessing medical devices in healthcare settings. Marie Thibault After digesting last week’s...
Mar 18, 2015
Marie Thibault Insulin pumps have drawn plenty of attention over the past few years for increasing user adoption, collaborations between diabetes device...
Mar 17, 2015
Despite being a regular target for criticism, FDA’s Center for Devices and Radiological Health is scoring high on its customer satisfaction survey. Marie...
Mar 17, 2015
Government dysfunction can be seen in the Centers for Medicare and Medicaid Services' efforts to put the brakes on linking unique device identifiers with...
Mar 16, 2015
Learn details about the potential impact of the new European Medical Device Regulation (EMDR) for medical device manufacturers and suppliers of outsource...
Mar 12, 2015
Marie Thibault Despite regulation that requires reporting of trial results, the large majority of applicable trial data is not reported, according to a new...