Medical Device and Pharmaceutical News
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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 Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as...
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 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...