US Approved Device for Battlefield Injuries Despite Serious Risks, Former FDA Reviewer Says
The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...
'We've Been Getting Picked Off': Product Liability Lawsuits Are Struggling
Attorney Simon Purnell of Griffin Purnell said he thinks the courts' view of preemption is a "fundamental misunderstanding of ...
The Cairns Post22d
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor is executing a modular review process with the FDA, whereby modules covering ... is involved due to the number of devices for which we are seeking approval simultaneously.
Yahoo Finance12d
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
TCET is meant to expedite Medicare coverage for new medical devices once approved by the FDA. The program ... Oz agreed that ...
NBC New York1mon
FDA moves to rehire medical device staffers fired only days earlier
effective FDA review process that helps advance the medical technologies American patients depend on.” FDA staffers said entire teams of five or more medical device reviewers had been reinstated.
JD Supra15d
US Emerging as Top Global Medtech Destination
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE ...
Yahoo Finance13d
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...
The Australian23d
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor Medical Systems (ASX:IMR) – which has developed the world’s only MRI-compatible devices for ... the US Food and Drug Administration’s (FDA’s) premarket approval (PMA) process ...