Tag Archives: FDAgpt

Getting a medical device to market is a complex journey involving design, development, and meticulous adherence to regulatory requirements. A top-tier quality management system (QMS) like Greenlight Guru Quality is crucial for pre-market MedTech companies, providing essential tools to manage documentation, secure necessary approvals, and maintain a compliant, traceable system. Greenlight Guru has been instrumental […]

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Data management and reporting are pivotal aspects of conducting FDA-regulated clinical trials for medical devices. Ensuring the precision, security of clinical data, and adherence to Good Clinical Practice (GCP) are vital for the success of your study and subsequent regulatory submissions to the FDA. This article offers a detailed guide on the FDA’s guidance and […]

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In this insightful episode of the Global Medical Device Podcast hosted by Etienne Nichols, discussions zone in on the critical subject of the FDA’s proposed rule concerning wound dressings. Joining Nichols are two expert guests: Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at the […]

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Abbott reported higher-than-anticipated results in its second-quarter earnings, spurred by significant growth in its medical device sector. The company recorded a quarterly revenue of $10.38 billion, marking a 4% increase from the previous year. Medical devices emerged as a strong contributor, with sales rising to $4.73 billion, a solid 10.2% year-over-year increase. Notably, electrophysiology, structural […]

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Phathom Pharmaceuticals has recently introduced a novel treatment for heartburn sufferers with its newly FDA-approved drug, vonoprazan, marketed under the brand name Voquezna. This drug offers a fresh approach to managing gastroesophageal reflux disease (GERD), particularly the most common form of the condition known as non-erosive GERD. This new approval extends Voquezna’s use, following its […]

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The original text provided lacks sufficient detail to be summarized to 800 words. The available information only mentions that the FDA released its Spring 2024 Unified Agenda, which includes plans for upcoming regulations in 2024 and beyond. There are seven new proposed rules and updated target publication dates for some significant regulatory actions highlighted in […]

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Over the last year and a half, the medical device industry has experienced significant job cuts, shedding over 14,000 positions across the United States. These layoffs have not just affected large firms; companies of all sizes within numerous medical technology sectors have been impacted. The need to curtail operational expenses, close down facilities, or reorganize […]

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Huma, a UK-based healthcare technology company, recently announced that it has raised more than $80 million in its latest funding round, a Series D, escalating its total funding to over $300 million. Notable new and returning investors participated in the round, including pharmaceutical giant AstraZeneca, Leaps by Bayer, Hat Technology Fund 4 by HAT SGR, […]

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The Food and Drug Administration (FDA) has recently undertaken a significant reorganization of its Center for Devices and Radiological Health (CDRH) as a strategic move to fulfil its commitments under the Medical Device User Fee Amendments (MDUFA) V and to address the growing demands of modern healthcare technology. This restructuring involves vital changes in several […]

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Alzheimer’s disease, a neurodegenerative disorder, has been traditionally targeted through treatments focusing on the amyloid protein plaques in the brain, with recent drug approvals such as Eisai’s Leqembi and Eli Lilly’s Kisunla leading the way. These intravenously infused therapies use antibodies to break up amyloid proteins but come with risks such as bleeding and brain […]

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