Navigation Links
BioElectronics Continues FDA Clearance Campaign to Bring Chronic Pain Sufferers Safe, Effective, Inexpensive, Drug-Free Pain Therapy
Date:6/10/2013

FREDERICK, Md., June 10, 2013 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, which has sold 500,000 devices, without prescriptions, in 57 countries reported that they have received three letters from the Office of Science Integrity.  These letters are virtually identical in denying the firm's request for the FDA Commissioner to review her staffs' prior decisions.  Dr. Jesse Goodman, Chief Scientist, said, "I have determined, in my discretion, that additional Agency consideration is not warranted" and simply suggested resubmitting 510(k) premarket notifications or "providing input into the recent CDRH process for reclassification of non-thermal shortwave diathermy devices." 

Andrew Whelan, President of BioElectronics said, "Despite the FDA's egregious delays associated with applications initially filed in 2009, and our primary international business focus, we plan to continue to pursue all possible avenues to get OTC market clearance and bring to American consumers the same safe and affordable pain relief enjoyed by people around the world."

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

Page: 1

Related medicine technology :

1. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
2. BioElectronics ActiPatch Reduces Muscle Soreness in Runners
3. Clinical Interest in BioElectronics Products Expands to the Wound Care Market
4. BioElectronics Corporation Announces Indian Distributors Ecommerce Website
5. BioElectronics Corporation Announces Initiative for UK and German Markets
6. BioElectronics Topical Pain Therapy Now Available Throughout Europe
7. BioElectronics Expands South America Distribution
8. BioElectronics Announces South Korean Patent Allowance for its Innovative OTC Pain Relief Medical Devices
9. BioElectronics Expands to the Czech & Slovak Republic
10. Gro-International to Develop BioElectronics OTC Brands in European and African Markets
11. BioElectronics Announces Publication of Patent Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... , June 23, 2016 Bracket , a ... its next generation clinical outcomes platform, Bracket eCOA (SM) ... on June 26 – 30, 2016 in Philadelphia ... electronic Clinical Outcome Assessment product of its kind to fully ... Bracket eCOA 6.0 is a flexible platform for ...
(Date:6/23/2016)... RIDGE, Ill. and INDIANAPOLIS ... of students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship ... The 2016 scholarship winners, announced today online at ... to let type 1 diabetes stand in the way ... Diabetes has supported the Foundation,s scholarship program since 2012, ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):