Diabetes data management company Tidepool is one of nine companies working with the FDA as part of the agency’s digital health pre-certification pilot program. In a blog post published yesterday, the company’s founder, president & CEO wrote that he hopes industry works to keep up with the evolving regulatory landscape and that the FDA should work to make its pre-certification process scalable to companies of all sizes.
The chief exec, Howard Look, specifically noted that he has urged the agency to ensure that any pre-certification process open to companies like Apple (NSDQ:AAPL) also be available to open-source diabetes projects.
On June 4-5, DeviceTalks is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring, bringing you the best and brightest minds in the industry.
Heidi Dohse: Sr. Program Manager, Healthcare, Google, Founder, Tour de Heart Foundation, Acessa Health Inc. Michael J. Pederson: Senior Vice President, Cardiac Arrhythmias and Heart Failure Division, Abbott Hon. Melvin Carter: Mayor, Saint Paul Tim Philips: Compliance Officer, FDA’s Office of Medical Device and Radiological Health Operations Dr. Myriam J. Curet, MD, FACS: Chief Medical Officer, Intuitive Surgical
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