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Fdanewsdevicedailybulletin

Aug. 17, 2012

Vol. 9 No. 162

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Deficiency Letter, IDE Review Changes May Be Among MDUFA Gifts to Industry

Higher user fees and the FDA’s corresponding pledge to improve performance at CDRH stole the spotlight during the Medical Device User Fee Act (MDUFA) reauthorization process earlier this year. Read More

ASEAN Draft Medical Device Directive Would Beef Up Adverse Event Reporting

Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer. Read More

Recall: Covidien Pulls Breathing Tubes Over Leak Concerns

Covidien recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation. Read More

New Microscope Detects Cancer Deep Inside Body

Tiny mechanical microscopes — those that can see inside single living cells — are increasingly being used to diagnose illness in hard-to-reach areas of the body. Read More

Thirty-five New Jobs as Spiddal Device Company Secures Investment From Helix Medical

Cambus Teo has secured investment from Helix Medical, a global manufacturer for the medical device and healthcare industries, which will create 35 jobs. Read More

Jarvik Heart Announces Full FDA Approval of the Jarvik 2000 Destination Therapy Trial

Jarvik Heart announced full FDA approval of its Pivotal Trial for evaluation of the Jarvik 2000 heart for destination therapy named RELIVE. Read More

SMCC Gets Medical Device Manufacturing Grant

Continuing a long-time tradition of working with local employers to provide workforce training, a grant from the Maine Quality Center will allow Southern Maine Community College (SMCC) to provide training in the growing field of medical device manufacturing. Read More

Medical Devicemaker to Close Boone County Plant, Lay Off Workers

It was one of the most successful life science startups in Central Indiana, got bought out for an enviable price by a much larger company — and now will suffer the unwelcome fate of a phased shutdown. Read More