Over the past two decades, the Army’s Role 3 hospital centers have achieved a 98% survivability rate—the highest in the history of modern warfare. The U.S. military’s ability to deliver unmatched ...

Anyone who has used a mechanical or technological device knows that devices tend to break down over time, and in few industries is this more manifest -- and more important -- than in healthcare.

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Figure 1. (click to enlarge) Part-level flow simulation. The diversity and complexity of medical devices are likely to increase with time, as will the associated design risks and manufacturing ...

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total ...

MOORESVILLE, N.C.--(BUSINESS WIRE)--Crothall Healthcare Technology Solutions (HTS) and Asimily, a leader in connected medical device inventory, cyber-security and operational management, are pleased ...

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...