The Medical Futurist

JUNE 17, 2025

We’ve all been through this as a kid and childhood memories stick with us, just recalling this might send a shiver down your spine. No one likes to go to the dentist although everyone knows how crucial oral health is and how strongly it is connected to our overall health. For patients, it promises more accurate care and better outcomes.

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. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! Globally 1.1

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

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. Accordingly, only a subset of 510(k) submissions have historically included HF validation data. 9, 2022).

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. During an inspection, FDA learned that Medtronic had opened a CAPA to address complaints of damaged retainer rings in these pumps (more than 74,000 between June 2016 and November 2019, with more than 57,000 reported to FDA as MDRs).

Medical 40

Medical Management Manufacturing Patients 40

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The statute achieves this through disclosure of information by the software manufacturer about the “basis for” the recommendations made by the software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical 69

Medical Physicals IT Healthcare Professional 69