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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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...
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 Obsidio Conformable Embolic products. The recall affects products distributed between May 8, 2023, and February 8, 2024. Product Details ...
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 regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing. Its cautionary...
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FDA Warning Letter to Jackson Clinic
Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and...
FDA Approval for Cancer Treatment Aid
The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent's Resolution CTDX FIRST, a new in vitro diagnostic (IVD) medical device for use in the detecting a specific mutation in the KRAS gene in circulating cell-free DNA. This test...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the Alzheimer's disease treatment Leqembi. This is a significant milestone in the fight against Alzheimer's, a debilitating and progressive brain...
FDA Issues Letter to Warn of Abbott Trifecta Valve Risks
Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare providers concerning potential risks associated with Abbott Trifecta valves. The Trifecta valve is a type of heart valve that is implanted in patients during...
FDA Alert: Abiomed Impella Blood Pump Controller
Abiomed Impella blood pump controllers Controller May Fail to Detect Device Abiomed has issued an urgent safety notice for...
China Implements a Ban on European Medical Devices
Growing China-EU Trade Conflict The medical device industry is now the latest battleground in a growing China-EU trade...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia...
FDA Approves DATROWAY® Breast Cancer Treatment
A new breast cancer treatment option The United States Food and Drug Administration (FDA) approved DATROWAY® (datopotamab...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for...
Beware of False “Cures” for Autism
Unapproved and Potentially Harmful Products Autism Spectrum Disorder (ASD) affects about 1 in 68 children, and while early...
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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