The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Running trials in animals will take additional engineering and safety tests. Developing bionic eyes with fractal-patterned electrodes for reversing blindness We have seen fascinating developments as well.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei graduated magna cum laude , with a degree in Biomedical Engineering with a concentration in Electrical Engineering from The George Washington University. While at FDA, Ms. During her FDA tenure, Ms.

Engineering 59

Engineering Manufacturing Specialization Management 59

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.

Manufacturing 64

Manufacturing Engineering Medical IT 64