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Recently, two ophthalmology practice groups — Kleiman Evangelista Eye Centers of Texas (KEEC) and SouthEast Eye Specialists, PLLC (SEES) — reached large settlements with the U.S....
Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission.
On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...
The United States needs more public fast charging stations with more EV infrastructure for EV charging.
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.