Correction on Medtronic’s InterStim neurostimulator
This article was originally published in The Gray Sheet
Executive Summary
The sacral nerve neurostimulation implant, for which Medtronic recently submitted a PMA application for treatment of fecal incontinence, was originally approved in 1997 for urinary incontinence. "The Gray Sheet" had erroneously reported that the urinary indication was first approved in 2006 (1"The Gray Sheet" Oct. 27, 2008, In Brief)
You may also be interested in...
Medtronic InterStim
Firm submits a PMA application for treatment of fecal incontinence with the neurostimulation implant, anticipating a U.S. launch in 2009, Medtronic announces Oct. 22. The device, which works by stimulating the sacral nerve, has been approved since 2006 for urinary incontinence (1"The Gray Sheet" July 10, 2006, In Brief)
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.