By Deborah Bell, executive director of business development in Australia, Avania Whether to control costs or to recruit a larger population, medical device manufacturers are looking beyond the U.S., the EU, and Asia to conduct clinical trials. When planning global studies and early commercialization, Australia is a strongly considered market. The access to innovative medical […]
Avania
Avania acquires IMARC
Avania today said it has acquired medical device clinical research outfit IMARC for an undisclosed amount. Strongsville, Ohio–based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training. Get the full story on our sister site, Medical Design & Outsourcing.
How to secure Medicare coverage for your IDE clinical trial
By Jennifer Varela, Senior Manager, Reimbursement at Avania Mack Rubley, Executive Director, Business Development (US) at Avania Admittedly, requesting reimbursement for investigational device exemption (IDE) clinical trials in the United States is a complex, daunting process frequently overlooked by medical device manufacturers. However, if payers — most notably the U.S. Centers for Medicare and Medicaid […]
MDR might be delayed but that doesn’t mean your plans to implement should be
Alwin van den Broek, Project Manager and Data Protection Officer Anne Leijsen, Director, Medical Writing Long before the pandemic, medical device companies were scrambling to meet the European Union’s new Medical Device Regulations (MDR), slated for adoption on May 26, 2020. As COVID-19 began to take hold of the world in March 2020, the Trade […]
DeviceTalks Weekly: Ep.7 – Edwards, employment news, update on clinical trials from Avania
In this week’s episode of DeviceTalks Weekly, Tom Salemi and Chris Newmarker stare at each other through the Zoom lens while talking about the positive employment news from Baxter International and Conformis, the hopeful news from Edwards Lifesciences, and the cautionary tone from Medtronic. What can we expect from the rest of medtech? In the […]
Factory CRO Group rebrands as Avania
Medtech contract research organization Factory-CRO Group is changing its name to Avania. Formed Boston-based Boston Biomedical Associates (Marlborough, Mass.), Factory CRO (Bilthoven, Netherlands), Five Corners (Artarmon, Australia), and MileStone Research Organization (San Diego), Avania said it will bring together regional teams of experts across a wide range of therapeutic specialties, including medical devices, novel technology, […]