Electronics Manufacturing Medical Patients 
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).
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The Medical Futurist
JUNE 21, 2025
The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa.
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
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. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,
FDA Law Blog
SEPTEMBER 22, 2024
MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. By Steven J. Gonzalez & Lisa M.
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. It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized.
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