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When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA).  Now, two years later and with major planning already underway regarding the future of FDA’s patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.

As med tech companies roll out innovative products to treat sleep disorders, electronics outfit Nintendo is looking to cash in on the trend with a new sleep-monitoring device that runs on its health-focused platform.

A blood test developed by Melbourne University (Australia) researchers can detect Alzheimer’s disease years before symptoms become apparent; a study has shown.  Researchers made the finding after testing 100 people for genetic material called microRNA, which circulates in the bloodstream.

The U.S. Food and Drug Administration announced in September 2014 The FDA awards grants for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.

UNICEF has paired with design firm Frog and smartphone chip maker ARM to search to save lives in underdeveloped countries.  The “Wearables for Good” challenge is intended to inspire design and technology experts and entrepreneurs to create wearables to improve health standards in these countries.

The U.S. market for large bone and joint orthopedic devices is expected to grow to approximately $2 billion by 2020, according to a new report from iData research.

The FDA’s device arm continued it’s light-touch approach to regulating medical software and other modern health information technologies that are either relatively simple or don’t pose a clinical risk to patients.  In technical terms, the FDA employed its “enforcement discretion,” meaning the agency believes it has the authority to regulate the devices but opts not to.

There were 426 medical device recalls in the first quarter of this year (2015), according to the FDA’s recall database, down from a record high of 968 in Q4 2014.

University of Pennsylvania researchers are in the early stage of developing a neural implant to help the 10 million people across the globe with traumatic brain injury improve their memory.

A national survey and study by doctors from the University of California, Los Angeles, found that defensive medicine is leading to unnecessary imaging.  In the survey, 97% of emergency physicians (EPs) acknowledged ordering some scans that were not strictly necessary.