Both companies believe that this hire will accelerate Focus Surgery’s (FSI’s) ability to expand its high intensity focused ultrasound (HIFU) technology platform.
As the director of regulatory affairs, Dr Millett will be developing strategies for regulatory approval of medical devices, coordinating submission activities for a variety of device regulatory approvals and the FDA meetings on the clinical activities and pre-market approval submissions. Dr Millett will also be serving as an internal consultant on general regulatory issues and managing assigned internal and external clinical activities.
Prior to joining FSI, Dr Millett was in charge of development of regulatory strategies for high risk, combination medical devices. Dr Millett has received his BS in chemistry from the University of California, Berkeley, and his PhD in chemistry from Stanford University.
Narendra Sanghvi, president of FSI, said: “Dr Millett’s experience working with the FDA will also enhance our ability to effectively move forward with additional applications of high intensity focused ultrasound technology that are under development at Focus Surgery and USHIFU.”