CHARLOTTE, NC. Friday, March 20, 2015 -- Today SonaCare Medical announced that the Company has filed with the FDA a submission for a De Novo grant of its Sonablate® 500 HIFU system for the transrectal ablation of prostatic tissue. This submission is in addition to the Company's Pre-Market Approval ("PMA") application and study which it is continuing to pursue. The De Novo process was first introduced in 1997, with the implementation of the FDA's Modernization Act (FDAMA), as a means to reclassify novel medical devices of low to moderate risk profiles that were automatically deemed Class III because no substantially equivalent devices existed to merit a successful 510(k) submission.

New certification allows SonaCare to market the world's first and only focused ultrasound ablation system platform

CHARLOTTE, NC. Monday, March 16, 2015 -- SonaCare Medical, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, announced today that it has received new broad CE Mark Certification for both its Sonatherm and Sonablate High Intensity Focused Ultrasound (HIFU) devices. The new CE Mark is for the design and manufacture of imaging and therapeutic ultrasound devices for imaging, planning, energy delivery and ablation tracking in support of soft tissue ablation. According to Dave Hernon, Director of Quality Assurance & Regulatory Affairs at SonaCare, "The new CE Mark represents an important regulatory expansion compared to the Company's current regulatory approval and further differentiates SonaCare as the only HIFU manufacturer with this broad degree of certification."

SonaCare Medical achieves a successful pilot using the Company's new remote monitoring software, Sonalink™.

CHARLOTTE, N.C., FEBRUARY 10, 2015 -- SonaCare Medical, LLC reports the introduction of a highly anticipated expansion to their comprehensive training and support program, Sonalink™ remote monitoring. The inaugural launch of this new technology occurred over the course of two Sonablate® HIFU procedures performed on Friday, February 5th, connecting Dr. Samuel Peretsman to a HIFU technical expert at SonaCare Medical headquarters.

Dr. Peretsman launches his U.S.-based prostate High Intensity Focused Ultrasound (HIFU) program in Huntersville, North Carolina by performing two HIFU procedures on the same day.

CHARLOTTE, N.C., JANUARY 13, 2015 -- SonaCare Medical, LLC announces the completion of two Sonablate® prostate tissue ablations performed by Dr. Samuel Peretsman. Both procedures were completed on Friday January 8th, 2016.

University of Southern California's Keck Hospital first to perform renal HIFU ablation in outpatient setting

SonaCare Medical announces that doctors at the University of Southern California (USC) have successfully used the new Sonatherm robotic High Intensity Focused Ultrasound (HIFU) technology to ablate renal cancer at Keck Hospital of USC. Dr. Inderbir Gill, MD, MCh founding executive director, USC Institute of Urology, and Chairman and Professor, Catherine and Joseph Aresty Department of Urology at the Keck School of Medicine of USC, performed this HIFU procedure, which was the first in the world in an outpatient setting.

SonaCare Medical Board of Directors to Include Members with Extensive Health Care and Executive Business Management Experience

CHARLOTTE, NC -- SonaCare Medical, a leading manufacturer of medical High Intensity Focused Ultrasound (HIFU) devices, announced today that five new members have been selected to serve on the company's Board of Directors. The new members bring additional health care industry experience to the Board and include a physician and hospital CEO, a president of multiple medical companies, two founders of investment firms, and SonaCare Medical's newly appointed CEO. The new Board members are Evan Bakst, Dr. Mark Carol, David Koslosky, Dr. Bruce Murphy, and Dr. John Wilkerson. They join the Chairman of the Board, Thomas Mendell, along with Co-Founder and Board Member, Stephen Puckett, Sr.

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HIFU company

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Latest News

11 January 2017

Charlotte, NC (PR Newswire) January 11th, 2017 - SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its...

05 October 2016

Charlotte, NC (PR Newswire) Oct 5th, 2016,  SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the device...