FDA clears first at-home brain device for depression

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...
STAT

Excitement and wariness as FDA shifts to much more flexible cell and gene therapy oversight

At a Food and Drug Administration cell and gene therapy (CGT) roundtable last June, most speakers pushed for the agency to ...

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Becker's Hospital Review

FDA clears AI imaging tool for brain metastases

The FDA has granted 510(k) clearance to Brain Mets, an AI-based software platform designed to aid in the detection, tracking and treatment planning of brain metastases. The tool, developed by Neosoma, ...