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Truvian Health Secures $74M in Funding for Automated Blood Testing Platform

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 […]

Startup GRObio Secures $60M to Challenge Amgen in Gout Treatment, Enters Clinical Stage

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 […]

How Four Pre-Market MedTech Firms Utilize Greenlight Guru Quality to Their Advantage

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 […]

Data Management and Reporting Practices in Clinical Trials Regulated by the FDA

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 […]

Regulatory Influence and Industry Impact Insights

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 […]

Abbott Provides Insight into Prescription-Free and Over-the-Counter Continuous Glucose Monitoring Markets

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 […]

Phathom Pharma’s Heartburn Medication Gains Expanded Approval for Wider GERD Patient Coverage

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 […]

Over 14,000 Job Cuts at Medtech Companies in the Last 18 Months

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 […]