The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. The de novo process allows FDA to establish new product ...

The Class I recall of McKesson's Anesthesia Care software provides clues as to what FDA considers to be high-risk clinical decision-support software and high-risk bugs. By Bradley Merrill Thompson On ...

To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...

Problematic software has been the cause of multiple infusion pump recalls in the medical device industry over the past few years.

The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...

The Food and Drug Administration has issued a Class I recall of McKesson Technologies Anesthesia Care software following an incident of a patient’s data appearing in another patient’s record. McKesson ...

Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability ...

Once again, Medtronic has issued a product correction for its surgical navigation software, earning the StealthStation platform its fifth Class I recall categorization from the FDA in as many years.