FDAnews Device Daily Bulletin

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.

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.

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

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.

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

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

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.

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.