Ativa Medical Corporation was selected as one of four medical companies in the Twin Cities to host a team of senior officials from the FDA’s Center for Devices and Radiological Health (CDRH) through a program organized by LifeScience Alley. In addition to Ativa, the FDA visited Medtronic, Boston Scientific and Lutonix to gain a better understanding of each company’s specific approach toward technology innovation and the associated testing and modeling techniques.

The primary objective of these meetings was to foster collaboration between medical companies and the FDA to reduce review times and improve decision making on regulatory submissions.

“We were honored to be selected by the FDA to participate in this program to share our unique and integrated approach toward technology development. We look forward to ongoing collaboration with the FDA as we continue to work through the regulatory process to bring our products to market in the US,” stated David Deetz, President and CEO.

Attending officials from the FDA’s Center for Devices and Radiological Health included:

Dr. Jeff Shuren, Director, CDRH

Dr. Alberto Gutierrez Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH

Dr. Bill Maisel, Deputy Director for Science, CDRH

Dr. Joel Myklebust, Deputy Director, OSEL, CDRH

Dr. Joni Foy, Acting Deputy Director for Science & Regulatory Policy, Office of Device Evaluation, CDRH

This exclusive meeting with Ativa Management allowed the FDA’s attendees to gain insight into the Company’s integrated product development quality modeling processes, and laid the foundation for greater collaboration with the agency in the future.

Ativa adds Dr. Bob Galen, to its independent Board of Directors. "Dr. Galen posseses an incredibly valuable understanding of both the technology and the market that Ativa is playing in," says CEO and President, David Deetz.