Category: fda

‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea

The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Thousands of medical devices are sold, and even implanted, with no safety tests.

Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

KFF Health News’ ‘What the Health?’: Democrats See Opportunity in GOP Threats to Repeal Health Law 

Sensing that Republicans are walking into a political minefield by threatening once again to repeal the Affordable Care Act, the Biden administration is looking to capitalize by rolling out a series of initiatives aimed at high drug prices and other consequences of “corporate greed in health care.” Meanwhile, the Supreme Court hears a case that could determine when and how much victims of the opioid crisis can collect from Purdue Pharma, the drug company that lied about how addictive its drug, OxyContin, really was. Alice Miranda Ollstein of Politico, Anna Edney of Bloomberg News, and Rachana Pradhan of KFF Health News join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews Dan Weissmann of KFF Health News’ sister podcast, “An Arm and a Leg,” about his investigation into hospitals suing their patients over unpaid bills.

KFF Health News’ ‘What the Health?’: Trump Puts Obamacare Repeal Back on Agenda

Although Republicans have never united behind a replacement for the Affordable Care Act, 2024 GOP presidential front-runner Donald Trump said this week he wants to put the issue back on the national agenda. That delights Democrats, who have won at least two elections partly by defending the now-popular health law. Meanwhile, the Texas Supreme Court takes up a case brought by women who say their pregnancy complications further endangered their health due to the vagueness of Texas’ near-total ban on abortions. Joanne Kenen of Johns Hopkins University and Politico Magazine, Sarah Karlin-Smith of the Pink Sheet, and Victoria Knight of Axios News join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews KFF Health News’ Rachana Pradhan, who reported and wrote the latest “Bill of the Month” feature.

Doubts Abound About a New Alzheimer’s Blood Test

Quest Diagnostics is selling a blood test online to consumers. But results may not be reliable or easy to interpret. And it isn’t covered by insurance.

California Moves Ahead of the FDA in Banning Common Candy Additives

The legislation bans the use of four additives that are already prohibited in many other countries but remain in popular U.S. foods. Advocates say states need to act because the FDA has done little.

PrEP, a Key HIV Prevention Tool, Isn’t Reaching Black Women

New HIV infections occur disproportionately among Black women, but exclusionary marketing, fewer treatment options, and provider wariness have limited uptake of preexposure prophylaxis, or PrEP, drugs, which reduce the risk of contracting the virus.

Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.

In a torrent of lawsuits, patients accuse Florida device maker Exactech of hiding knee and hip implant defects for years. The company denies the allegations.

KFF Health News’ ‘What the Health?’: Underinsured Is the New Uninsured

The annual U.S. Census Bureau report this week revealed a drop in the uninsured rate last year as more working-age people obtained employer coverage. However, this year’s end of pandemic-era protections — which allowed many people to stay on Medicaid — is likely to have changed that picture quite a bit since. Meanwhile, reports show […]