Navigation Links
SonaCare Medical Granted FDA Regulatory Clearance for Updated HIFU Prostate Tissue Ablation Device
Date:1/11/2017

CHARLOTTE, N.C., Jan. 11, 2017 /PRNewswire/ -- SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate® in the United States. Sonablate was the first HIFU device to receive regulatory authorization from the Food and Drug Administration (FDA) for the focused ablation of prostate tissue.

This improved version of Sonablate technology includes new and updated features such as: Tissue Change Monitoring (TCM™), a tool that quantifies RF signals for changes in tissue composition following energy delivery; altered delivery sequences that, in combination with a new and more automated planning system, reduces overall procedure time by as much as 40%; and a modernized look and feel to the software interface. 

Continue Reading
 (PRNewsFoto/SonaCare Medical, LLC)
(PRNewsFoto/SonaCare Medical, LLC)...

"We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorization SonaCare Medical received for Sonablate in 2015," comments Dr. Mark Carol, Chief Executive Officer. "We are appreciative of the efforts of the FDA to continue to advance the delivery of care for men who may benefit from prostate tissue ablation. Based on the adoption rates of Sonablate in the U.S. in 2016, we expect the placements and acquisitions of our technology to grow dramatically in 2017, bringing this ground-breaking approach to a greater percentage of men in the U.S."

Since Sonablate® received FDA clearance on October 09, 2015, there have been over 40 acquisitions of Sonablate® technology, including placements at top-tier academic institutions located in California, Indiana, Maryland, New York, and Texas.  Over 43 U.S. physicians now offer HIFU prostate tissue ablation to their patients, and over 700 U.S. patients have selected this minimally-invasive alternative to surgery or radiation.

About SonaCare Medical, LLC

SonaCare Medical is a world leader in minimally invasive focused ultrasound technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

For additional information, visit www.SonaCareMedical.com

Forward Looking Statements.
The Company's forward-looking statements are based on management's current expectations and assumptions regarding the Company's business and performance, the economy and other future conditions and forecasts of future events, circumstances and results. As with any projection or forecast, forward-looking statements are inherently susceptible to uncertainty and changes in circumstances. The Company's actual results may vary materially from those expressed or implied in its forward-looking statements. Any forward-looking statement made by the Company speaks only as of the date on which it is made. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, subsequent events or other factors.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sonacare-medical-granted-fda-regulatory-clearance-for-updated-hifu-prostate-tissue-ablation-device-300389108.html


'/>"/>
SOURCE SonaCare Medical, LLC
Copyright©2017 PR Newswire.
All rights reserved


Related medicine technology :

1. SonaCare Medical Expands Management Team With Chief Financial Officer
2. SonaCare Medical to Present at the 32nd Annual J.P. Morgan Healthcare Conference
3. Vasomedical Announces Financial Results for the First Quarter of 2013
4. CCS Medical Moves Forward as Medicare Winner
5. PENTAX Medical Launches Industrys Highest* Resolution HD+ Imaging Technology For Flexible Endoscopy
6. SOAPware President Randall Oates, M.D. Among First NCQA Certified Patient-Centered Medical Home Content Experts
7. RAD Technology Medical Systems Delivers Innovative Time Saving Modular Construction At New Swedish Cancer Institute Facility
8. PENTAX Medical And Hitachi-Aloka Medical Continue Joint Innovation And Global Leadership In Endoscopic Ultrasound Systems
9. ACLS Online Course Manuals are Now Available at No Cost through United Medical Education
10. Statistical Challenges in Medical Device Trail Evaluation
11. Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured during TAVR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):