The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Ames Gross, Pacific Bridge Medical
Indonesia has introduced updates to its electronic registration platform for medical devices, in preparation for its integration with the regulatory system of the Association of Southeast Asian Nations (ASEAN) in January 2015. It has also clarified rules for customs integration and declaring medical device accessories and spare parts.
Cook Medical touts FDA win for next-gen colonic stent
Cook Medical won FDA clearance for the latest of its Evolution line, the Colonic Controlled-Release stent.
Angioplasty balloon maker r4 Technologies wins FDA approval
Maple Grove, Minn.-based r4 Technologies landed FDA approval for its Vector percutaneous transluminal angioplasty balloon catheters, which come in 28 different sizes.
Correction June 26, 2012, at 11:15 am: This article mistakenly stated that the Senate approved the bill. The Senate had voted only to close debate on the measure, the final vote will occur this evening.
MASSDEVICE ON CALL — The U.S. Senate voted 89-3 to close debate on the latest iteration of the FDA’s user fee bill, which doubles the previous amount that medical device makers pay for agency review for new products.
