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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.
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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.
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Covidien recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation.
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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.
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Cambus Teo has secured investment from Helix Medical, a global manufacturer for the medical device and healthcare industries, which will create 35 jobs.
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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.
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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.
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