Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
FDA Approves Sentimag Magnetic Localization System for Biopsies
Magtrace® and Sentimag® Magnetic Localization System Novel sentinel lymph node localization technique without radiation On December 6, 2022, the U.S. Food and Drug Administration (FDA) approved PMA P160053 Supplement S002 for the Magtrace and Sentimag Magnetic...
Regulatory Documentation for National and Global Market Access
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...
FDA Announces Online Electronic 510(k) Submissions
The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Latest Posts
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by delivering electrical impulses to the spinal cord. The system typically consists of several components: Implantable Pulse Generator (IPG) This is the...
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, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs. This implanted system comprises a...
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 have access to cutting-edge, safe, and effective devices is paramount. Yesterday, the Center for Devices and Radiological Health (CDRH) released...
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, 2024. The report outlines the commitment of the Center for Devices and Radiological Health (CDRH) to ensuring the safety and effectiveness of...
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 the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...
Available in paperback and eBook formats on Amazon.
Click on the image or this link to see the book on the Amazon website.
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
Pharma