New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...

Seeking Alpha's Quant system consistently outperforms the S&P 500 ( SP500 ), driven by powerful computer processing and SA's ...

Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and ...

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent ...

The New Orleans Saints are excited to announce a new partnership with PatientPoint, the trusted leader in patient and ...

On the surface, making medical devices may not sound very exciting. But when you take a closer look, as in at the cellular level, it is quite remarkable.

Here are three recent recalls reported to the FDA: ...

Atos Medical's lease of 25,000 square feet in New Berlin was the area's largest office lease in the fourth quarter of 2024.

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...

Wearable devices can identify, differentiate, and predict flare-ups, or the worsening of symptoms and inflammation, in inflammatory bowel disease (IBD), Mount Sinai researchers have shown in a ...