The Latest
Medical device and pharma industry news and informationMedical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
- FDA enforcement news
- Regulatory updates
- Innovative products
- Compliance information, and
- Other industry headlines.
And do not forget to check our pages for consumer safety information and regulatory services.
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 Posts Warning Letter to MicroVention Costa Rica
Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to MicroVention Costa Rica SRL on September 30, 2022. The company is a subsidiary of MicroVention Inc., a medical device company based in Tustin,...
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 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...
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...
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...