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Tag Archive for: FDA

Posts

donanemab Kinsula

FDA under fire: Controversial Alzheimer’s drug donanemab approved amid excess death concerns and conflicts of interest

Alzheimer’s, donanemab, Eli Lilly, FDA, The BMJ, 26 September 2024/in dementia, E-News, Editors' Picks, Featured Articles, Patient Safety, pharmacology, Regulation /by panglobal

A new investigation of FDA-approved Alzheimer’s drug donanemab highlights concerns about excess deaths, missing safety data, and financial conflicts of interest among FDA advisory panel members who recommended approval.  

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https://interhospi.com/wp-content/uploads/sites/3/2024/09/donanemab_kinsula_web.jpg 800 1200 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2024-09-26 02:00:412024-09-25 13:29:05FDA under fire: Controversial Alzheimer’s drug donanemab approved amid excess death concerns and conflicts of interest

Single-dose gene therapy dramatically reduces bleeds in haemophilia B patients

FDA, gene therapy, haemophilia B, Research, 26 September 2024/in Congenital Diseases, E-News /by panglobal

A single-dose gene therapy has demonstrated significant reduction in bleeding episodes for adults with haemophilia B, potentially offering a long-term solution to this genetic disorder.  

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https://interhospi.com/wp-content/uploads/sites/3/2024/09/blood25.jpg 720 960 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2024-09-26 01:00:122024-09-25 13:03:21Single-dose gene therapy dramatically reduces bleeds in haemophilia B patients
Medtronic’s HeartWare Ventricular Assist Device recalled

Cardiovascular device recalls: Study reveals gaps in safety testing

FDA, medical devices, patient safety, regulation, 20 September 2024/in E-News, MedTech, Patient Safety, Regulation /by panglobal

A new study finds that most cardiovascular devices subject to the most serious recalls by the US FDA lacked rigorous clinical testing before approval, raising concerns about patient safety.  

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https://interhospi.com/wp-content/uploads/sites/3/2024/09/medtronic-1.-HeartWare-Ventricular-Assist-Device.jpg 824 1306 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2024-09-20 08:15:292024-09-19 14:11:27Cardiovascular device recalls: Study reveals gaps in safety testing
Sammy Chouffani El FassiSammy Chouffani El Fassi

Nearly half of FDA-approved AI medical devices lack real patient data training, study finds

AI, clinical validation, FDA, medical devices, 26 August 2024/in AI, E-News /by panglobal

A comprehensive analysis of FDA-approved artificial intelligence medical devices reveals significant gaps in clinical validation, raising concerns about their effectiveness and safety in real-world healthcare settings.  

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https://interhospi.com/wp-content/uploads/sites/3/2024/08/Sammy.jpg 800 800 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2024-08-26 11:03:592024-08-26 11:03:59Nearly half of FDA-approved AI medical devices lack real patient data training, study finds
Oticon Medical Sentio System

Oticon Medical’s transcutaneous bone conduction hearing system receives FDA clearance

FDA, hearing loss, Oticon Medical, Sentio System, transcutaneous, 15 July 2024/in Product News /by panglobal

Oticon Medical has announced that its Sentio System, the company’s first active transcutaneous bone conduction hearing system, has received clearance from the U.S. Food and Drug Administration (FDA). This innovative system aims to provide the established benefits of the company’s Ponto System whilst offering a transcutaneous option.

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https://interhospi.com/wp-content/uploads/sites/3/2024/07/Oticon_Sentio.jpg 662 716 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2024-07-15 09:13:322024-07-15 09:13:32Oticon Medical’s transcutaneous bone conduction hearing system receives FDA clearance

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