Medical Devices

Subterms

    Latest story

    163 Shares40 Views

    From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

    by

    The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

    More stories

    • 113 Shares169 Views

      in Elections

      Lawmakers Seek Inquiry Into F.D.A. Device Chief’s Potential Conflicts

      by

      A top medical device regulator’s work overlapped at times with his wife’s legal representation of clients with business before the agency.Two members of Congress have asked an inspector general to investigate whether the top federal regulator for medical devices like pacemakers and artificial hips acted ethically in work that overlapped with that of his wife, a leading lawyer for device companies.The lawmakers cited an investigation by The New York Times that examined the intersection of the work of the regulator, Dr. Jeffrey Shuren of the Food and Drug Administration, and his wife, Allison Shuren, a co-chair of the drug and medical device practice at the prominent Washington office of Arnold & Porter.The two House Democrats who wrote a letter seeking an inquiry are Representatives Anna Eshoo, of California and ranking member of the health subcommittee, and Rosa DeLauro, of Connecticut and ranking member of the appropriations committee.The Times found several instances in which the couple’s work overlapped and could have posed conflicts of interest requiring Mr. Shuren’s recusal. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have stepped aside or sought approval to be involved in two matters to “avoid any potential appearance of bias.”“In circumstances such as these,” the congresswomen’s letter to the inspector general, Christi Grimm, said, “the only way to get to the truth and be fair both to the public and Dr. Shuren is through an independent review of the matter to determine whether this is simply an appearance of impropriety or actual inappropriate and unethical conduct.”A spokeswoman for the inspector general’s office of the Health and Human Services Department said that the letter was received Tuesday and that “we are reviewing it for appropriate action.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

    • 125 Shares99 Views

      in Elections

      The Art Forger Had Fooled Thousands. Then He Met Doug.

      by

      When a man obsessed with woodblocks began to do business with a man obsessed with medical antiques, their relationship flowered — until it soured.Earl Washington loves wood.He loves maple wood from Wisconsin and boxwood from Turkey. He loves running his hands on its surface, feeling its heft and texture. But most of all he loves carving it. Thoughts about carving, he says, consume his waking moments.“If I’m looking at your face when I’m talking to you, I’m literally looking at how I’m going to carve your eyes and carve your nose on a piece of wood,” he said in an interview.For decades, beginning in the late 1990s, Washington, 62, created thousands of ornate woodblocks and used them to make intricate prints of all kinds of things: biblical imagery, erotica, anatomical illustrations, the stark motifs of German expressionism.Mastery was never enough for him, though. To profitably sell woodblocks — which can be an oddity in the art market — Washington decided he also needed myth. So he created elaborate origin stories for his pieces. Some, he claimed, had been made or acquired by his great-grandfather. Others he promoted as rare creations from the 16th and 17th centuries.Thousands of people bought them unquestioningly, but a few became suspicious and raised concerns online and to the authorities. The F.B.I. fielded some complaints, but was not aware, it said later, of the “depth and the breadth” of Washington’s scheme, so he continued to sell his creations, having mastered the craft of carving and the art of fooling others.Until one day in 2013, when he met Douglas Arbittier.Everything Earl Washington feels about wood, Arbittier feels about medical antiques.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More