Laws & Regulations

Family Sues Yale New Haven Health Over Fatal Tele-ICU Care
Digital Health Family Sues Yale New Haven Health Over Fatal Tele-ICU Care

The promise of modern telemedicine often relies on the assumption that digital monitoring complements rather than replaces the physical presence of a skilled physician at a patient's bedside during a crisis. This delicate balance was allegedly shattered at the Bridgeport Hospital Milford Campus

Can Home Medical Devices Cut Hospital Readmission Rates?
Regulatory & Compliance Can Home Medical Devices Cut Hospital Readmission Rates?

The sterile environment of a hospital ward is increasingly being traded for the familiar comfort of the living room as healthcare providers rethink the recovery process. With nearly one in five chronic care patients returning to a clinical setting within a month of discharge, the medical community

Distalmotion Targets U.S. Outpatient Market with FDA Filing
Regulatory & Compliance Distalmotion Targets U.S. Outpatient Market with FDA Filing

James Maitland has spent the better part of two decades at the intersection of robotics and patient outcomes, witnessing firsthand the transition of surgery from massive hospital theaters to more agile, outpatient environments. As an expert in IoT and medical robotics, he has navigated the complex

How Will MHRA and FDA Cooperation Shape Medtech Regulation?
Regulatory & Compliance How Will MHRA and FDA Cooperation Shape Medtech Regulation?

A New Era of Transatlantic Regulatory Synergy The global medical technology landscape is currently witnessing a transformative shift as the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the United States Food and Drug Administration (FDA) deepen their strategic

CMS Faces Staffing Shortages Amid Major Policy Expansions
Regulatory & Compliance CMS Faces Staffing Shortages Amid Major Policy Expansions

The vast machinery of the Centers for Medicare and Medicaid Services is currently attempting to manage the healthcare needs of more than 160 million American citizens with a workforce that has dwindled by 1,000 employees over the course of the past calendar year. This significant reduction in human

FDA Clears VDyne to Launch Heart Valve Replacement Trial
Regulatory & Compliance FDA Clears VDyne to Launch Heart Valve Replacement Trial

Approximately 1.5 million individuals in the United States currently grapple with the debilitating effects of severe tricuspid regurgitation, a condition that has historically left many patients with few viable recovery options due to the high risks associated with traditional surgery. For decades,

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