Industry News

Mobile Health

Usability in Mobile Apps

Mobile apps have become a go-to platform for both patients and healthcare providers to manage medical care. Applying human factors and usability principles to the development of such apps is critical. Xcertia, and mHealth collaborative have been working to develop industry guidelines.


IFU New Guidance from FDA

The FDA has released a new draft guidance on the content and format across IFU's used for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA).


Transparency in Reporting

The FDA system of reporting has become more transparent recently. With that transparency the FDA has released over 20 years of records on medical device adverse events. FDA is working to update its Medical Device Reporting program, one of the tools they use to continue to ensure safety in the landscape of health care.


Black-Box Algorithms

This black box algorithm is the the latest road map to a blend of medicine and computers. What are the pitfalls and what are the benefits? How much real clinical knowledge is needed until this technology becomes feasible?


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