Tag Archives: FDAgpt

Qiagen announced a significant expansion of its collaboration with AstraZeneca, moving beyond oncology to focus on companion diagnostics for chronic diseases. This development marks a substantial new phase for the partnership, originally initiated a decade ago, which until now has predominantly centered around cancer. Qiagen is tasked with developing and validating a genotyping assay using […]

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Glytec, a leading diabetes and insulin management software company, has partnered with pharmaceutical giant Roche to integrate Glytec’s software with Roche’s cobas pulse system. This collaboration will be rolled out in both the U.S. and global markets, aiming to improve diabetes management in hospital settings. Roche’s cobas pulse is known for its advanced point-of-care smart-device […]

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Illumina, a prominent company in the field of genomic sequencing, has recently received approval from the Food and Drug Administration (FDA) for its TruSight Oncology (TSO) Comprehensive test. This advanced genetic test is designed to analyze variants across 517 genes using nucleic acids extracted from solid tumor tissue samples. The test employs Illumina’s Nextseq 550Dx […]

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Imidex, a medical device company leveraging AI for enhanced lung cancer detection, has recently formed a strategic partnership with Orbit Genomics, a specialist in DNA-sequencing technologies. Together, they aim to significantly reduce lung cancer fatalities by merging their distinctive technological solutions. Imidex is known for its FDA 510(k)-cleared VisiRad XR device, which efficiently detects lung […]

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Boston Scientific has achieved a significant milestone by receiving a CE mark for its latest transcatheter aortic valve replacement (TAVR) system, Acurate Prime. This new device represents an important improvement over its predecessor, the Neo2 valve system. Among the notable enhancements are the inclusion of a larger valve size, designed to cater to an additional […]

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Medicare, established in 1965, included a crucial mandate to cover only items and services deemed “reasonable and necessary” for treating illnesses or injuries. This guideline has traditionally meant that experimental or investigational treatments—those not yet fully proven effective—were not covered under Medicare, causing delays in adopting new, potentially beneficial medical technologies even after FDA approval. […]

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There are numerous unanswered questions about GLP-1 medications, including their side effects, effectiveness over time, and their impact on health inequities among different patient groups. In response to these uncertainties, OMNY Health has initiated a new data network aimed at enriching understanding and enhancing the application of these drugs in diverse patient populations. OMNY Health, […]

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Inari Medical, a healthcare company, has initiated a recall of their ClotTriever XL catheters, a device used for removing clots and obstructions from major blood vessels outside the heart, according to a recent announcement by the Food and Drug Administration (FDA). This action comes after the identification of serious issues linked to the device, which […]

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Former President Donald Trump and Vice President Kamala Harris, potential contenders in a fierce political arena, have found common ground on one significant issue: the need for governmental intervention in reducing high U.S. drug prices. Despite their polarizing politics, both have exhibited a commitment to reining in the burgeoning costs that burden the American healthcare […]

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Insulet, a prominent medical device company, has gained significant regulatory approval from the Food and Drug Administration (FDA) for its latest insulin pump designed for use by individuals with Type 2 diabetes. This approval marks a pivotal development as it introduces the first automated insulin delivery (AID) system, frequently referred to as an “artificial pancreas,” […]

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