Month: July 2024

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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The U.S. House Appropriations Committee has requested that the Food and Drug Administration (FDA) halt its efforts to finalize regulations on laboratory developed tests (LDTs). This request was made in legislative proposals related to the funding of the FDA and other federal bodies for the fiscal year 2023. The committee, which passed the appropriations bill […]

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I apologize for any misunderstanding, but it seems like there was an error or a limitation in providing the full article text for review. The information you’ve provided is an introduction, likely to a full piece which discusses the updated FDA guidance on how life sciences companies can address misinformation about their products online. From […]

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