Regulation

Can New FDA Guidelines Reduce Racial Bias in Pulse Oximeters?
Technology Can New FDA Guidelines Reduce Racial Bias in Pulse Oximeters?

The U.S. Food and Drug Administration (FDA) has recently issued new guidelines to tackle the issue of racial bias in devices that measure oxygen levels in the blood, known as pulse oximeters. These guidelines arose from the importance of this issue during the COVID-19 pandemic, when inaccuracies in

How Should AI-Enabled Medical Devices Be Monitored Postmarket?
Technology How Should AI-Enabled Medical Devices Be Monitored Postmarket?

In a groundbreaking move to ensure patient safety and device efficacy, the FDA has recently issued comprehensive guidance on the lifecycle management of AI-enabled medical devices, emphasizing the importance of proactive monitoring and long-term performance management. This directive addresses the

Are Pulse Oximeters Accurate Across Different Skin Tones?
Data and Information Are Pulse Oximeters Accurate Across Different Skin Tones?

The accuracy of pulse oximeters, devices commonly used to estimate blood oxygen levels, has come under scrutiny due to evidence suggesting performance discrepancies across different skin tones. This issue has prompted the US Food and Drug Administration (FDA) to propose new draft guidance aimed at

Hospital M&A in 2024: Stability on the Surface, Distress Underneath
Business Hospital M&A in 2024: Stability on the Surface, Distress Underneath

The year 2024 has been a paradoxical one for the hospital and health system sector. On the surface, the industry appears to be stabilizing, with improved operating margins and positive outlooks from key rating agencies. However, a deeper analysis reveals ongoing financial distress and significant

Targeting Taurine Metabolism: A New Frontier in Obesity Treatments
Public Policy Targeting Taurine Metabolism: A New Frontier in Obesity Treatments

The intricate relationship between diet, weight, and metabolism has long been a subject of scientific inquiry. Recent research led by Jonathan Long, a biochemist at Stanford University, delves into how specific dietary components influence bodily functions, particularly in terms of energy balance

How Can PE Investors Navigate Healthcare and Life Sciences Sector?
Technology How Can PE Investors Navigate Healthcare and Life Sciences Sector?

Private equity (PE) investments in the healthcare and life sciences sector have become increasingly attractive due to the sector's potential for high returns. However, navigating this complex landscape requires a deep understanding of the unique challenges and opportunities it presents. The

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