The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The Biden administration is considering creating a quicker process to review new medical devices for Medicare coverage after a controversial Trump-era rule was scrapped. Officials with the Centers ...

“This significant milestone highlights the platform potential of SetPoint's device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy V. Simhambhatla, Ph.D ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet deadlines mandated by Congress due to Trump administration layoffs, three ...