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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Urgent Action Required – Baxter LIFE2000 System
Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced that Baxter International Inc. has issued an urgent medical device correction for its LIFE2000 Ventilation System. An issue with the device’ software may...
FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear medicine systems manufactured by GE Healthcare. The recall involves the 600/800 Series nuclear medicine systems, which are used to diagnose and...
FDA announces recall of LivaNova LifeSPARC System
The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical device used for circulatory support during heart surgery. The recall was initiated due to the potential for the device to experience unintentional...
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by...
Implementation of the EU MDR and IVDR
A Significant EU Regulatory System Overhaul The implementation of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represents a significant overhaul of the regulatory framework governing medical devices and...
FDA Approves XACT Carotid Stent System
A Breakthrough for Stroke Prevention Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Three Companies Recall Blood Pressure Medication
All recalled products had unacceptable levels of nitrosamines Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer...
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Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...
CPAP Machines
What Is a CPAP Machine? A CPAP (Continuous Positive Airway Pressure) machine is a medical device used primarily to treat sleep apnea, a condition characterized by pauses in breathing or shallow breaths during sleep. CPAP therapy involves delivering a continuous...
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. Today, a...
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
Canine microRNA Biomarkers and Osteosarcoma Diagnostics
The Diagnostic Problem Despite advances in surgery and chemotherapy, survival outcomes for osteosarcoma have changed little...
Canine Osteosarcoma Immunotherapy and Human Research
Osteosarcoma Osteosarcoma is a devastating bone cancer with limited treatment progress over decades. In humans, it remains...
Do Not Blame FDA for Lax Oversight of Dietary Supplements
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting...
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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