In the article, “Lured by a bigger payday, a medical device maker sold fake plastic parts. Many were implanted in chronic pain patients,” Stat News covered the story of the company Stimwave’s device fraud that became widespread news in March. They interviewed Dr. Victor Krauthamer, a visiting biomedical engineering professor at GW, for his expertise on the matter as he spent three decades working at the FDA.
Here is an excerpt from the article: “The FDA is charged with making sure devices are safe and effective before they hit the market. But they’re not equipped to spot unnecessary components, like Stimwave’s receiver, that could defraud patients, doctors, and insurers.” Visiting Professor of Biomedical Engineering at GW and former director of the division of biomedical physics at the FDA, Victor Krauthamer, said, “employees at the agency are swamped and particularly limited by a dearth of data with the 510(k) process.”
Read the full article on Stat News.