USHIFU, LLC Announces the Hiring of Dr. Ian Millett to Serve as Director of Regulatory Affairs for Focus Surgery, Inc.

    CHARLOTTE, N.C., Oct. 3 /CNW/ -- USHIFU, LLC, a privately held healthcare
development company and the exclusive distributor of the minimally invasive
Sonablate(R) 500 for prostate cancer treatment in North and South America, the
Caribbean and India, announced today the hiring of Dr. Ian Millett on
September 8, 2008, as Director of Regulatory Affairs of Focus Surgery, Inc.
(FSI). FSI is the designer and manufacturer of the Sonablate(R) 500 medical
device. Both companies believe that this hire will accelerate Focus Surgery's
ability to expand the FSI HIFU (high intensity focused ultrasound) technology
    "We are excited to announce the addition of Dr. Ian Millett as the
Director of Regulatory Affairs. With his extensive experience from inside the
FDA as well as successful PMA and 510k track record, Ian will play an integral
role in building out our HIFU technology platform," said Steve Puckett, Jr.,
CEO of USHIFU. "Ian shares our vision that the prostate modality is only the
beginning of major technological innovation in store for HIFU."
    "Dr. Ian Millett will accelerate our organization's efforts for clearance
for both the recurrent and primary prostate cancer clinical trials," said
Narendra Sanghvi, President of FSI. "Dr. Millett's experience working with the
FDA will also enhance our ability to effectively move forward with additional
applications of HIFU that are under development at Focus Surgery and USHIFU."
    As the Director of Regulatory Affairs, Dr. Ian Millett will be developing
strategies for regulatory approval of medical devices, coordinating submission
activities for a variety of device regulatory approvals and leading FDA
meetings on the clinical activities and PMA submissions. Dr. Millett will also
be serving as an internal consultant on general regulatory issues and managing
assigned internal and external clinical activities.
    Dr. Ian Millett received his B.S. in Chemistry from the University of
California, Berkeley, and his Ph.D. in Chemistry from Stanford University.
Prior to joining FSI, Dr. Millett was in charge of development of regulatory
strategies for high risk, combination medical devices, development of
regulatory strategies for introducing innovative Class III medical
technologies and oversaw the preparations for submissions world-wide for a
leading international medical device company. He has also worked with the FDA
to approve and streamline the approval of medical devices and combination
medical products.
    The Sonablate(R) 500 is not approved for use in the U.S. The Sonablate(R)
500 remains investigational in the U.S. and is being studied for the treatment
of prostate cancer in clinical trials in the U.S. FDA has made no decision as
to the safety or efficacy of the Sonablate(R) 500 for the treatment of
prostate cancer. Currently, the device is available for the treatment of
prostate cancer in Canada, the Dominican Republic, Argentina, the Bahamas and

For further information:

For further information: Amanda Willis, USHIFU, LLC, +1-704-936-1823, Web Site:

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