Month: September 2024

Samsung Medison, a medical device subsidiary of the South Korean tech giant, recently announced its acquisition of Sonio, a French medtech startup specializing in enhancing fetal ultrasound efficiency with AI. This acquisition marks a significant step for Samsung in deepening its footprint in the healthcare sector. Founded in 2020, Sonio has rapidly gained attention for […]

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NeOnc Technologies, a biotech company from Westlake Village, California, is pioneering a new method for treating aggressive brain cancers, such as glioblastoma, by circumventing the blood-brain barrier through intranasal drug delivery. The company’s primary innovation, NEO100, uses perillyl alcohol (POH), a natural compound found in essential oils, delivered directly to the brain via inhalation, targeting […]

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AI regulation in healthcare continues to be an evolving field that requires a focus on transparency and understanding, as emphasized by Luke Raston during a recent presentation at the Heart Rhythm Society’s HRX conference in Atlanta. Ralston, a seasoned biomedical engineer and scientific reviewer at the FDA, stressed that regulating AI is a nuanced process […]

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Eli Lilly is advancing its development of a once-weekly insulin, efsitora alfa, designed for people with diabetes, bringing it a step closer to competing with similar products like Novo Nordisk’s already available insulin icodec. As part of a comprehensive Phase 3 program which includes five studies — four focusing on type 2 diabetes and one […]

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Travere Therapeutics, a San Diego-based biotech company, has received full FDA approval for their drug Filspari, which treats immunoglobulin A nephropathy (IgAN), a rare disease where excessive antibody production leads to kidney damage. Previously granted accelerated approval based on its ability to reduce proteinuria—a sign of kidney disease—Filspari’s full approval comes after demonstrating significant long-term […]

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Signia, a prominent hearing aid manufacturer, has recently unveiled its latest advancement in hearing technology: the Signia Active Pro Integrated Xperience (IX) earbuds. These devices not only serve as state-of-the-art earbuds but also fulfill the criteria for prescription-grade hearing aids, blending aesthetic appeal with high-tech functionality. The core innovation in these new earbuds is the […]

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In 2023, a new analysis by ECRI and the Institute for Safe Medication Practices revealed that roughly one-third of adverse patient safety events reported by healthcare providers involved diagnostic testing errors. The analysis determined that the majority of these mistakes, nearly 70%, occurred during routine processes, such as ordering tests, collecting samples, or reporting results. […]

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Abbott, a prominent global healthcare company, has launched its innovative continuous glucose monitoring system called Lingo, which is now available for purchase in the U.S. without a prescription. This system is designed for individuals over 18 years old who are not using insulin. It incorporates technology based on Abbott’s FreeStyle Libre system, which has already […]

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In a significant legal ruling, Johnson & Johnson (J&J) has been ordered by a Delaware judge to pay over $1 billion to the former investors of Auris Health, a surgical robotics firm acquired by J&J in 2019. This verdict is the result of J&J’s failure to adhere to the terms of the merger agreement which […]

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The Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning their marketing of devices intended to clean continuous positive airway pressure (CPAP) machines. These devices, which claim to employ methods such as ozone gas or ultraviolet (UV) light, lack FDA clearance or approval. Specifically, the FDA has advised that it […]

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