The Medical Futurist

JUNE 17, 2025

In comparison, the first VR-recorded surgery was performed at the Royal London Hospital in 2016. Teledentistry If you are reluctant to go to the dentist, imagine how hard it is for children, patients with special needs or the elderly in nursing homes.

Patients 126

Patients Treatment Plan Healthcare Medical Specialty 126

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. Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

FDA Law

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.” Special 510(k)s. This example suggests that the prospects are poor for adding cyber features via a Special 510(k).

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law

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

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

Provider 59

Provider Medical Manufacturing Consulting 59