Four U.S. government agencies have issued an advisory regarding bias in the use of artificial intelligence (AI) and other automated systems, the scope of which includes software products that “make decisions.” The four agencies have pledged to use their enforcement powers to “protect individuals’ rights regardless of whether legal violations occur through traditional means or advanced technologies,” all of which sends a signal to developers of medical software that the FDA is not the only federal government agency that will be looking over their shoulder to evaluate the risk of bias in those algorithms.
The neonatology unit at Bonn University Hospital (UKB) in Germany conducted the world’s first study of portable magnetic resonance imaging at the bedside on children undergoing extracorporeal membrane oxygenation (ECMO) therapy. This procedure involves oxygenating the blood outside the body. The 10-strong neonatology team demonstrated that it is safe and feasible to perform portable MRI at the bedside in this patient population.
A pill that delivers electrical stimulation to the vagus nerve from inside the stomach was able to trigger the release of appetite-controlling neurohormones, specifically the “hunger hormone” ghrelin.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
The Memed BV test, developed by Memed Diagnostics Ltd. to distinguish between bacterial and viral infections, offers an accurate diagnosis of the infection in children, and reduces the unnecessary prescription of antibiotics by physicians, according to a study published in the journal, PLOS One.
The 10-year update to Medtronic plc’s ENGAGE registry for its Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated high degrees of protection from aneurysm and sac regression in a real-world setting. The results were presented at the 2023 Charing Cross Symposium in London on April 26.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardiex, Galderma, Ultromics, Vyspine.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotechnologies, Cardiac Dimensions, Concertai, Corza, Genadyne, Guardant, Infervision, Infusystem, Lifespin, Sectra, Spring Software, Takeda.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carl Zeiss Meditec, Insulet, Proprio.
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