Tag Archives: Compliance

Truvian Health, a company specializing in blood-testing technology, recently announced that it has raised $74 million in funding, securing partnerships with notable entities such as Shoppers Drug Mart, Canada’s largest pharmacy chain. The funding round was co-led by Great Point Ventures and Wittington Ventures, with additional contributions from existing investors like Medical Excellence Capital, Tao […]

Continue Reading

For patients suffering from gout, a painful form of arthritis caused by excess uric acid in the blood, conventional treatments may not always provide relief. In such cases, Amgen’s biologic drug has been a potential alternative, yet its effectiveness is often limited by the immune system which might recognize the therapeutic protein as foreign, initiating […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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, […]

Continue Reading