Regulatory & Compliance

Integra Lifesciences Recalls Cranial Drills Over Safety Defects
Regulatory & Compliance Integra Lifesciences Recalls Cranial Drills Over Safety Defects

In a challenging turn of events for Integra Lifesciences, a significant recall of their cranial drills has brought intense scrutiny upon the company, emphasizing the inherent risks found in medical device manufacturing. These cranial drills, specifically the Codman cranial perforators, have been

GOP Healthcare Law: 10 Million Uninsured and Rising Deficit
Regulatory & Compliance GOP Healthcare Law: 10 Million Uninsured and Rising Deficit

In an era where healthcare policy plays a pivotal role in shaping societal welfare, the Republican-led healthcare law signed on July 4 sparked notable debate across professional and public spheres. The legislation, commonly referred to as the “One, Big Beautiful Bill” Act, has the potential to

Is Blood Pressure Tech Wellness or Medical Device?
Infrastructure & Management Is Blood Pressure Tech Wellness or Medical Device?

Blood pressure technology is experiencing a significant surge in interest and innovation, with a complex debate regarding its classification as either a wellness device or a medical instrument. This conversation, sparked by a recent dispute between the FDA and wearable tech company Whoop, is

States Sue Over Changes to Trump Administration's ACA Rules
Regulatory & Compliance States Sue Over Changes to Trump Administration's ACA Rules

Could Tweaks to Healthcare Policy Strip Millions of Coverage? Amid the evolving landscape of healthcare regulations in America, a fierce legal battle is unfolding over modifications to the Affordable Care Act (ACA) orchestrated by the Trump administration. This contentious move has prompted over 20

Why Are Arterial Cannulas Being Recalled?
Regulatory & Compliance Why Are Arterial Cannulas Being Recalled?

In the rapidly advancing field of medical technology, unforeseen challenges occasionally arise, even among industry leaders. James Maitland, an expert in robotics and IoT applications in medicine, brings his deep knowledge to discuss the intricate details of a recent recall by Edwards Lifesciences.

Humana Battles CMS Over Medicare Ratings for Financial Gains
Regulatory & Compliance Humana Battles CMS Over Medicare Ratings for Financial Gains

In an evolving healthcare landscape, Humana Inc. finds itself at a crossroads, challenging the Centers for Medicare and Medicaid Services (CMS) over star ratings critical to financial success. As Humana seeks to recalibrate its Medicare Advantage ratings, this analysis delves into the broader

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