Posts Tagged ‘devices’

March 16th, 2015

Selections from Richard Lehman’s Literature Review: March 16th

This week’s topics include endovascular therapy for ischemic stroke with perfusion-imaging selection, innovation and implementation in CV medicine, statin intolerance, and more.

April 3rd, 2013

International Cardiovascular Device Registries: The Next Big Thing

A new initiative involving a wide variety of stakeholders — the FDA, the American College of Cardiology, the Society of Thoracic Surgeons, industry, medical journals, and others — could lead to an enormous international cooperative effort to make device registries a standard part of the practice of cardiology. This will be a “huge step,” said David […]

March 11th, 2013

Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13

How are devices regulated? Due to some quirks, the tail now wags the dog.

July 29th, 2011

Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]

March 1st, 2011

CV Device Trials Still Fail To Include More Women

Women continue to be significantly underrepresented in trials of cardiovascular devices, according to a study published in Circulation: Cardiovascular Quality and Outcomes. Sanket Dhruva and colleagues performed a systematic review of the PMA applications for 78 high-risk cardiovascular medical devices submitted to the FDA from 2000 to 2007. Despite repeated attempts to call attention to the issue […]