Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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Prospera Spinal Cord Stimulation System for Intractable Back Pain
Prospera Spinal Cord Stimulation System FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System,...
A Look at the CDRH 2024 Innovation Report
Revolutionizing Medical Device Innovation In a world where medical technology evolves at a rapid pace, ensuring patients...
CDRH Issues its 2024 Safety Report
2024 CDRH Safety Report The FDA Center for Devices and Regulatory Health issued its CDRH 2024 Safety Report on April 17,...
Fresenius Kabi Recalls Ivenix Infusion Pump Software
Urgent Class I Recall Notice A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of...
Urgent Recall for Boston Scientific Obsidio Conformable Embolic
Urgent Class I Recall Notice Boston Scientific Corporation issued a critical recall notice on February 20, 2024, for its...
FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose
FDA Safety Communication On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
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