After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, ...

On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...

One day before the U.S. Food and Drug Administration’s (FDA) deadline for medical device companies to submit Class III product data to the FDA’s Production Global UDI Database (GUDID), GHX announced ...

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. The recall comes years after surgeons say they ...

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...

Since launching in 2017, an ambitious and secretive Food and Drug Administration program to speed up medical device development has helped at least 44 authorized devices hit the market. There are now ...

It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value. In my mind, the data can simply become what they claim to be. But it’s good to ...