2016 Manufacturing Provider Specialization 
The Medical Futurist
JUNE 17, 2025
Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth. These provide real-time feedback via a companion app warning you if you are applying too much pressure, where you are brushing and even coach the user as to how to brush properly.
The Medical Futurist
JUNE 21, 2025
In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. The journal Nature provided a commentary report on HKUST’s research into the bionic eye. Are 3D printed and digital contact lenses the future?
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FDA Law Blog
APRIL 25, 2023
Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. It applies whether the software is the entire device (i.e.,
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.
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