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Regulatory Roundup

Indonesia introduces updates to medical device accessories rules, e-registration system

January 10, 2014 By MassDevice Leave a Comment

asia

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.

Filed Under: News Well Tagged With: Pacific Bridge Medical, Regulatory Roundup

FDA OKs AtriCure’s AF ablation post-approval study | Regulatory Roundup

September 17, 2012 By MassDevice staff Leave a Comment

 AtriCure wins FDA OK to launch post-approval clinical study of AF ablation

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Ablation, AtriCure Inc., Regulatory Roundup

Asthmapolis wins FDA clearance for new sensor and software | Regulatory Roundup

July 12, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Asthmapolis obtains clearance for new sensor and app software

Filed Under: 510(k), News Well Tagged With: Asthma, Links Medical, Propeller Health, Regulatory Roundup, VisionCare Ophthalmic Technologies

Medtronic wins expanded FDA indication for snoring implant | Regulatory Roundup

July 12, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Medtronic obtains expanded indication for snoring treatment system

Filed Under: News Well Tagged With: BioMedEcon, Given Imaging, Regulatory Roundup

Derma Sciences wins CE Mark for honey-based wound dressing | Regulatory Roundup

July 11, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Derma Sciences obtains CE Mark for Medihoney HCS dressings

Filed Under: News Well Tagged With: Capricor Inc., Derma Sciences Inc., Regulatory Roundup, Syneron Medical Ltd.

Cook Medical lands FDA win for Evolution colonic stent | Regulatory Roundup

July 11, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 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.

Filed Under: News Well, Stents Tagged With: BioMimetic Therapeutics Inc., Cook Medical, Regulatory Roundup, Restoration Robotics Inc.

Angioplasty balloon maker wins FDA approval | Regulatory Roundup

July 6, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 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.

Filed Under: News Well Tagged With: Baxano Surgical, r4 Technologies, Regulatory Roundup, W.L. Gore & Associates

Brainsway wins 6th CE Mark for Deep TMS to treat chronic pain | Regulatory Roundup

July 4, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Brainsway wins CE Mark approval for chronic pain brain-stim implant

Filed Under: Neuromodulation/Neurostimulation, News Well Tagged With: Abbott, Brainsway, ETView Medical, Regulatory Roundup

FSS lands extended CE Mark for FlexStent | Regulatory Roundup

June 29, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 FSS touts CE Mark win for new self-expanding stent sizes

Filed Under: 510(k), News Well Tagged With: Flexible Stenting Solutions, InTouch Health, Regulatory Roundup, SHL Telemedicine, Surefire Medical, Synergetics USA Inc.

Bausch & Lomb wins FDA clearance for bio-inspired contact lenses | Regulatory Roundup

June 28, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Bausch & Lomb touts FDA clearance for bio-inspired Biotrue contacts

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Optical/Ophthalmic Tagged With: Bausch + Lomb, Elekta, Regulatory Roundup, Vyzin

Senate votes 89-3 to progress FDA user fee act | MassDevice.com On Call

June 25, 2012 By MassDevice staff Leave a Comment

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

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: MDUFMA, On Call, Regulatory Roundup, U.S. Congress, U.S. Senate

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