Get the latest tech news

Brain biopsies on 'vulnerable' patients at Mt Sinai set off alarm bells at FDA

A STAT Investigation: Brain biopsies on "vulnerable" patients at Mount Sinai set off alarm bells at FDA, documents show.

“I just [was] kind of willing to sign anything to expedite the process, so I did.” At that point, he was living in a nursing home and had debilitating symptoms: tremors, difficulty gripping with his hands, and trouble walking. What Bauman couldn’t have known was that roughly one year earlier, the Mount Sinai brain biopsies had set off alarm bells at the Food and Drug Administration, whose review had been triggered when a device manufacturer wrote to the agency in April 2019. The FDA’s months-long internal examination of the LBP yielded a series of documents seen by STAT, including a lengthy review, completed in August 2019, of the Mount Sinai study.

Get the Android app