The Medical Futurist

JUNE 17, 2025

Artificial intelligence Already, dentists employ software to get insights into clinical decision-making, but AI is changing the face of dentistry, just like it is in many other fields. But AR also found a home in dentistry for both educational and clinical purposes.

Patients 126

Patients Treatment Plan Healthcare Medical Specialty 126

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

The Medical Futurist

JUNE 21, 2025

In 2015, surgeons in Manchester, UK have performed the first bionic eye implant for an AMD patient using Second Sight’s innovation. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. She spoke of her joy after being able to tell the time for the first time in more than six years.

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law

SEPTEMBER 26, 2024

What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock. The Breakthrough program started in 2015.

Clinic 64

Clinic IT Manufacturing Medical 64

FDA Law

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.” Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.”

Manufacturing 59

Manufacturing Hospital Patients IT 59

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. I understand that it can be a hard place clinically.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96