Clinic Electronics Manufacturing Medical 
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.
FDA Law Blog
DECEMBER 12, 2022
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
FEBRUARY 9, 2024
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.
The Medical Futurist
JUNE 21, 2025
However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. EyeDecide can fully demonstrate the consequences of cataract or AMD and thus help patients understand their actual medical state.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.
FDA Law Blog
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
FDA Law Blog
FEBRUARY 15, 2023
By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. Manufacturers, therefore, have ample time to familiarize themselves with the changes.
Expert insights. Personalized for you.
70 
Let's personalize your content