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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The...

FDA Roundup: December 27, 2024
For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products indicated...

New Hope for Stomach Cancer: Combining Immunotherapy and Chemotherapy Before Surgery
What Did the Research Discover? Gastric and gastroesophageal junction (G/GEJ) cancers are among the deadliest cancers, and while immunotherapy has become a standard treatment for advanced cases, its role in earlier-stage disease is not well understood. The PANDA trial...

Elafibranor: A Promising New Treatment for Primary Biliary Cholangitis
What Did the Research Discover? Primary biliary cholangitis (PBC) is a rare liver disease that gradually damages the bile ducts, leading to liver scarring. If left untreated, it can progress to cirrhosis and severe liver disease. The current first-line treatment,...

Effective Treatments for Post-Inflammatory Hyperpigmentation in People with Darker Skin Tones
What Did the Research Discover? Post-inflammatory hyperpigmentation (PIH) is a condition where dark spots appear on the skin after an injury, inflammation, or irritation. It is especially challenging to treat in people with darker skin tones (Fitzpatrick skin types...

Risk Factors for Chronic Low Back Pain: What You Should Know
What did the research discover? This study found that nearly one-third (32%) of patients with acute low back pain (LBP) transitioned to chronic LBP within six months. The risk of developing chronic pain was significantly associated with: Higher scores on the Subgroups...

How Managing Anxiety Could Lower Your Risk of Dementia: What You Need to Know
What Did the Research Discover? Researchers studied whether benzodiazepine use is linked to a higher risk of dementia or cognitive decline in older adults. The study followed 3,434 participants aged 65 and older in Seattle, Washington, who did not have dementia at the...

Magnetic Seizure Therapy: A Promising Treatment for Major Depression
What did the research discover? Researchers studied two different treatments for major depressive disorder (MDD): Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT). They wanted to see which one worked better for treating depression and which had fewer...