Tag: medical devices

AAMI, CTA partners to develop healthcare AI standards

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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By: Matt Danford
October 3, 2024
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Odin Medical’s AI-powered device for colonoscopy receives FDA clearance

Editor's Note Odin Medical, a subsidiary of Olympus Corporation, received Food and Drug Administration (FDA) 510(k) clearance for its cloud-based AI technology, the CADDIE™ computer-aided detection device, PRNewswire September 5 reports. Designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy, the AI-powered system analyzes real-time video footage and alerts…

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By: Tarsilla Moura
September 11, 2024
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FDA announces Class 1 recall for ventilator adapter assemblies

Editor's Note The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death. The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit…

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By: Matt Danford
September 5, 2024
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APIC calls for improved medical device reprocessing instructions, guidelines

Editor’s Note The Association for Professionals in Infection Control and Epidemiology (APIC) is advocating for clearer reprocessing instructions for medical devices to improve patient safety and efficiency, Outpatient Surgery Magazine August 19 reports. Many current instructions for use (IFUs) are considered overly complex, outdated, and difficult to interpret, especially for…

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By: Tarsilla Moura
September 4, 2024
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Some FDA-recalled medical devices remain in use while manufacturers implement corrections

Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…

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By: Tarsilla Moura
August 27, 2024
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Handheld, powered surgical tools combine advantages of traditional laparoscopy, robotics

Editor's Note Combining dexterity and cost-effectiveness, handheld robotic devices offer potential to bridge the gap between traditional laparoscopy and more expensive robotic platforms, researchers concluded August 8 in the journal Surgery. The mini-review of clinical trials covered clinical applications of three handheld robotic devices: the HandX powered laparoscopic instrument from…

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By: Matt Danford
August 26, 2024
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FDA announces Class 1 recall for chest compression devices

Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop  compressions in adults whose hearts suddenly stop, according to the…

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By: Matt Danford
August 23, 2024
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Battery problem prompts FDA Class 1 recall for infusion pumps

Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…

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By: Matt Danford
August 21, 2024
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FDA: Ventilator death, injury reports lower than initially reported

Editor's Note:  Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…

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By: Matt Danford
July 18, 2024
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FDA announces Class 1 recalls for ventilator software, electrode pads

Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…

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By: Matt Danford
July 12, 2024
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