Laws & Regulations

FDA Warns ICU Medical for Unapproved Infusion Pump Changes
Regulatory & Compliance FDA Warns ICU Medical for Unapproved Infusion Pump Changes

In the rapidly evolving field of medical devices, staying compliant with regulatory requirements can be challenging. To shed light on this complex field, we speak with James Maitland, a seasoned expert in robotics and IoT applications within healthcare. His insights are particularly valuable given

Precision Neuroscience Gains FDA Approval for BCI Device
Regulatory & Compliance Precision Neuroscience Gains FDA Approval for BCI Device

In this captivating interview, we delve into the innovative world of Precision Neuroscience, exploring their groundbreaking advancements in brain-computer interface technology. James Maitland, an expert in robotics and IoT applications in medicine, provides fascinating insights into the company's

Can Arkansas' New Law Curb PBMs' Influence in Drug Pricing?
Regulatory & Compliance Can Arkansas' New Law Curb PBMs' Influence in Drug Pricing?

In a groundbreaking legislative move, Arkansas has enacted a law that prohibits pharmacy benefit managers (PBMs) from owning or operating pharmacies within the state. This pioneering legislation, signed by Governor Sarah Huckabee Sanders, aims to combat the rising costs of prescription medications

CMS Rejects Humana's Appeal Over Medicare Star Ratings Drop
Regulatory & Compliance CMS Rejects Humana's Appeal Over Medicare Star Ratings Drop

The Centers for Medicare & Medicaid Services (CMS) rejected Humana's internal appeal to enhance its Medicare Advantage star ratings. This decision, impacting Humana's Medicare Advantage program, was disclosed in a court filing amidst ongoing litigation against the U.S. Department of Health and

How Does ISO 13485:2016 Elevate Medical Device Translation?
Regulatory & Compliance How Does ISO 13485:2016 Elevate Medical Device Translation?

Translation services play a critical role in ensuring the accuracy and compliance of medical device documentation, affecting both patient safety and regulatory adherence across global markets. Recently, Milestone Localization, a leading player in translation and localization services, earned the

Will Tariffs on Pharma Imports Boost U.S. Drug Production?
Regulatory & Compliance Will Tariffs on Pharma Imports Boost U.S. Drug Production?

Examining the Potential for Enhanced Domestic Drug Production The Trump administration's decision to investigate the impact of pharmaceutical imports on national security has sparked a significant discussion regarding the potential imposition of tariffs. This probe aims to evaluate whether these

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