The Medical Futurist

JUNE 21, 2025

Large language models will soon find their way in to everyday clinical settings , simply because the global shortage of healthcare personnel is becoming dire and AI will lend a hand with tasks that do not require skilled medical professionals. Current medical AIs only process one type of data, for example, text or X-ray images.

Healthcare 70

Healthcare Healthcare Professional Electronics Medical 70

The Medical Futurist

JUNE 21, 2025

Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. While it is really difficult to manufacture a contact lens, which is one-third of a millimetre in diameter, a 3D printer sandwiches together different layers of interacting material, which makes it easier to match tiny pieces.

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

JANUARY 5, 2023

The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. FDA has shown a willingness to intervene in this space.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

MAY 21, 2024

Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. Findings The CSA requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse. 21 U.S.C. § Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614.

Physicals 69

Physicals Medical Clinic Emergency Room 69