Navigation Links
BioElectronics and Pulsed Shortwave Therapy Make Progress
Date:5/23/2013

FREDERICK, Md., May 23, 2013 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of very effective, safe consumer medical devices, comments on the FDA panel meeting for non-thermal shortwave diathermy:

The FDA's Public Advisory Panel Reclassification – Pulsed Shortwave Therapy Meeting was held on May 21, 2013 in Gaithersburg, MD, USA.  The focus of the meeting was very narrow, in that the FDA had instructed the panel to focus solely on the application of non-thermal shortwave diathermy for the treatment of postoperative pain and edema and the treatment of edema following blepharoplasty.  Industry representatives, including BioElectronics President Andy Whelan , presented a compelling case for reclassification.  The recommendation from the FDA's advisory panel was reclassification from Class III to Class II with special controls including a requirement for new clinical data. At this time it is not clear if the requirement for new clinical data applies to existing products.  The FDA will make a final decision on the recommendations of the panel in due course, though BioElectronics believes that the FDA will follow the panel's recommendations.

"Overall, we see the advisory panel and the FDA's recommendations as a positive and potentially significant development," stated Ian Rawe , BioElectronics Director of Clinical Research.  "After decades of use and research, the FDA now believes that the available evidence suggests that shortwave devices can be safely regulated. If existing cleared devices are compelled to submit new clinical data, our 3rd Molar Extraction clinical study at Tufts Dental School, Boston, meets all the FDA's clinical research standards. This study is evaluating both postoperative pain and edema, with edema being quantified with a 3D digital imaging system (http://www.3dmd.com/). Therefore, because of these expected developments and with expanded clinical research in place we are confident of moving forward."

We also continue to press our Petitions in the FDA's Commissioner's Office of Science Integrity for our musculoskeletal and menstrual pain market clearances and we are optimistic that this reclassification concession will help expedite market clearances. 

About BioElectronics Corporation

BioElectronics (www.bielcorp.com) is an award winning developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal ailments, the Allay™ Menstrual Cycle Pain Therapy, and RecoveryRx™ for surgical procedures and wound care.

Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com

 

 

 


'/>"/>
SOURCE BioElectronics Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. BioElectronics Presents FDA Reclassification Panel
2. BioElectronics New Patent Published
3. BioElectronics to Ease pain in Iraq
4. BioElectronics Selects New South Korean Distributor for its Healing and Pain Products
5. BioElectronics Obtains Additional US Patent For Its Unique Pain Devices
6. BioElectronics Enters Malaysias Pain Relief Market
7. BioElectronics Unique Pain Relief Product Featured on Leading Healthcare Show in Spain
8. BioElectronics Announces Chronic and Postoperative Wound Care Product Distribution in Italy
9. BioElectronics CEO Honored by Chabad at Johns Hopkins Medicine
10. BioElectronics Expands European Distribution to Malta
11. BioElectronics Announces Publication of Patent Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Research and Markets has announced ... Diagnostic Tests" report to their offering. ... The World Market for Companion Diagnostics covers ... Market analysis in the report includes the following: ... Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... Forecast to 2022" report to their offering. ... the patients with kidney failure, it replaces the function of ... patient,s blood and thus the treatment helps to keep the ... balance. Increasing number of ESRD patients & ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, ... and the Road To Recovery® program to drive cancer patients to and from their ... to ensure the highest quality of life and ongoing independence. Getting to and ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The ... published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , ...
Breaking Medicine News(10 mins):