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 imag
'/>"/>

SOURCE BioElectronics Corporation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:12/17/2014)... 17, 2014  Northstar Global Business Services, Inc. ... (DTC) has made their final decision and has ... Company,s stock effective December 15, 2014, and has ... depository and book entry transfer services. All deposit restrictions ... once again fully "DTC Eligible", and has resumed ...
(Date:12/17/2014)... SCOTTSDALE, Ariz. , Dec. 17, 2014 /PRNewswire/ ... of state-of-the-art interactive music products, today announced that ... Ltd, a leading manufacturer and supplier of innovative ... As part of the agreement, RSL ... Facility bundled solution specifically configured for use within ...
(Date:12/17/2014)... LOS ANGELES , Dec. 17, 2014 /PRNewswire/ ... that the US Patent and Trademark Office (USPTO) ... candidate ICT-107, a dendritic cell-based immunotherapeutic vaccine targeting ... glioblastoma. The claims of US Patent No. 8,871,211, ... treating neural cancer by administering a dendritic cell ...
Breaking Medicine Technology:Northstar announces that the DTC chill on MDIN has been officially lifted 2Northstar announces that the DTC chill on MDIN has been officially lifted 3Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2
(Date:12/17/2014)... parents should leave prenatal picture-taking to medical professionals, the ... ultrasound imaging and heartbeat monitors to get "keepsake" images ... "Although there is a lack of evidence ... monitors, prudent use of these devices by trained health ... engineer, said in an agency news release. "Ultrasound ...
(Date:12/17/2014)... HealthDay Reporter TUESDAY, Dec. ... fast approaching, a new study reveals that states that routinely ... drunk drivers on their roads. The finding suggests that ... able to deter inebriated revelers from getting behind the wheel ... being passed regarding drinking and driving," said study lead author ...
(Date:12/15/2014)... 2014 A recent survey found that ... as impacting skin health and beauty were: “Connections,” “climate,” ... care.” Water and health advocate and radio host Sharon ... describing the survey and the Four C’s.* Kleyne notes, ... category discussed would benefit from paying attention to one’s ...
(Date:12/15/2014)... December 15, 2014 Main Street Dental ... is weighing in on a new study providing evidence ... the oral hygiene of children. , Sufficient enough evidence ... such as pop or juice drinks, with the onset ... however, is whether drinks listed as 100% fruit juice, ...
(Date:12/15/2014)... 2014 OutMarket , a provider ... Social Media Cheat Sheets ,” a guide that exposes ... results on the top ten social media networks. ... drive awareness, engagement, and customer service. It can also ... an impact on new networks and weather constantly changing ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Enforcement of Drunk Driving Laws Makes Roads Safer, Study Finds 2Health News:Enforcement of Drunk Driving Laws Makes Roads Safer, Study Finds 3Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 2Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 3Health News:Main Street Dental Team, Unionville’s Most Innovative Dental Clinic, Comments on New Study Relating Pure Fruit Juice to Poor Oral Hygiene 2Health News:OutMarket Releases Cheat Sheets for Social Media Marketing 2Health News:OutMarket Releases Cheat Sheets for Social Media Marketing 3
... through in the medical field was seen when Pharma major ... who were the instigators for the vaccine//, marketed the latest ... in India and various measures are to be taken to ... a virus which has an incubation period of almost a ...
... quarrels and arguments can delay wound healing according to a ... edition of New Scientist//. ,.,Researchers at Ohio State University ... arguments for about half hour daily can have delayed wound ... problems can also cause reduced body immunity. ,42 married ...
... which intends to stabilize the rates of HIV by the ... US dollars to HIV infected individuals on a monthly basis//. ... HIV infection to below 0.3 percent by 2010. The current ... ,Under a recent government decision, poor HIV carriers living ...
... patient with Her-2/neu positive was helped by her Wangaratta ... drug which costs her more than $70,000.// The fund ... community which could help her to buy Herceptin drug ... more resistant to chemotherapy and anti-estrogen therapy such as ...
... a novel finding that love and addiction may go ... the physiological effects manifested as a result of dopamine ... more than a simulation of the effects observed following ... love and drug abuse leaves the user with an ...
... program with safe and tolerable exercise can be given ... them to have a better heart function//. The study ... of Cardiologist, Jonathan Rhodes. ,The study was ... 8 to 17 with severe congenital heart disease and ...
Cached Medicine News:Health News:‘Marriage Squabbles’ bad for both Emotional and Physical Wound 2Health News:Love And Drug Addiction Share The Same Chemistry 2
...
...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Medicine Products: