Tag Archives: Medical Devices

Sybil Shainwald, Lawyer Who Fought for Women’s Health, Dies at 96

Sybil Shainwald, Lawyer Who Fought for Women’s Health, Dies at 96

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 was 48 years old and …

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Trump’s Next Tariffs Target Could be Foreign-Made Pharmaceuticals

Trump’s Next Tariffs Target Could be Foreign-Made Pharmaceuticals

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; and Stelara, Johnson & Johnson’s …

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FDA Approved Artificial Blood Vessel Despite Warnings

FDA Approved Artificial Blood Vessel Despite Warnings

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 track of one. Four died. …

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Dr. Sheldon Greenfield, Who Exposed Gaps in Health Care, Dies at 86

Dr. Sheldon Greenfield, Who Exposed Gaps in Health Care, Dies at 86

Dr. Sheldon Greenfield, whose pioneering research found that older patients with breast and pancreatic cancer got subpar treatment and that patients who grill their doctors during consultations receive better care, died on Feb. 26 at his home in Newport Beach, Calif. He was 86. The cause was colon cancer, his daughter Lauren Greenfield said. Dr. Greenfield was a founder and …

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For Patients Needing Transplants, Hope Arrives on Tiny Hooves

For Patients Needing Transplants, Hope Arrives on Tiny Hooves

More than 100,000 Americans are on waiting lists for donor organs, most needing a kidney. Only 25,000 human donor kidneys become available each year. Twelve Americans on the kidney list die every day on average. Scientists first transplanted genetically engineered pig organs into other animals and then to brain-dead human patients. In 2022, researchers received permission to transplant the organs …

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F.D.A. Reinstates Fired Medical Device, Food and Legal Staffers

F.D.A. Reinstates Fired Medical Device, Food and Legal Staffers

The Food and Drug Administration has reinstated dozens of specialized employees involved in food safety, review of medical devices and other areas who were laid off last week, according to more than a dozen workers who got called back. The total number of employees recalled was not immediately clear. But a person familiar with the conversations said nearly all of …

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Firings at FDA Decimated Teams Reviewing AI and Food Safety

Firings at FDA Decimated Teams Reviewing AI and Food Safety

In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past. Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like …

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New Insights Into Older Hearts

New Insights Into Older Hearts

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 45 to 64, but in …

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New Insights Into Older Hearts

New Insights Into Older Hearts

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 45 to 64, but in …

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ExThera Claimed Its Device Could Cure Cancer. But Patients Died.

ExThera Claimed Its Device Could Cure Cancer. But Patients Died.

The private jet took off from the Caribbean island of Antigua in April carrying three highly flammable tanks of compressed oxygen and a terminally ill cancer patient. Kim Hudlow had chartered the plane for her husband, David. She crouched by his side on the five-hour journey to Florida, frantically adjusting the valve on one of the oxygen tanks as he …

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