Medical Devices and Pharma
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Latest Posts
Camber Recalls Atovaquone Oral Suspension USP
Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug...
Prodigy Proclaim Spinal Cord Stimulation Systems
Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation (SCS) systems. This approval marks a significant step forward in...
Exposure to toxic materials during hemodialysis and dialysis
FDA announcement The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter to healthcare providers regarding the potential risks of exposure to toxic compounds when using hemodialysis and peritoneal dialysis. This update...
FDA Breakthrough Devices Program
Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate...
Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA's Breakthough...
FDA Explores Dental Device Safety Concerns
Dental Devices to Treat Sleep Apnea and TMD The FDA is currently evaluating safety concerns related to certain dental devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep...
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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.
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