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The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but…
Sybil Shainwald, a lawyer who for nearly half a century represented women whose health had been irreparably and often catastrophically harmed by poorly tested drugs and medical devices, died on April 9 at her home in Manhattan. She was 96. Her daughter Laurie Shainwald Kleeger announced the death, which was not widely reported. Ms. Shainwald…
As a maker of prosthetic eyes, Christina Leitzel was told as an apprentice to treat her craft much as an expert art forger would: create a perfect match of one of nature’s most intricate canvases. But just as there are many ways to lose an eye — to cancer or to a fall; to a…
Newer and more expensive medications are more likely to be made in the United States or Europe. Ireland, in particular, has become a hub because it is a tax haven. Many of the industry’s biggest blockbusters are manufactured at least partly in Ireland. Among them are: Keytruda, Merck’s cancer drug; Zepbound, Eli Lilly’s weight-loss drug;…
When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person. As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost…
A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say the proliferation of Chinese health-care devices in the U.S. medical system is a cause for concern across the entire ecosystem. The Contec…
It turns out that the Isley Brothers, who sang that 1966 Motown hit “This Old Heart of Mine (Is Weak for You),” were onto something when they linked age to an aching and flagging heart. Heart disease, the nation’s leading cause of death and disability, has been diagnosed in about 6 percent of Americans ages…
