Fidelity SPDR Advertisement
Home > Boards > US OTC > Medical - Drugs > Bioelectronics Corp. (BIEL)

BIEL~~FDA Approval news this AM....

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
GEM Member Profile
Member Level 
Followed By 3,361
Posts 49,494
Boards Moderated 0
Alias Born 07/22/11
160x600 placeholder
Facebook Survey Shows UK Consumers Experience 52% Reduction in Intractable Chronic Pain with ActiPatch® Therapy in Musculosk... "PR Newswire (US)" - 8/26/2014 8:30:00 AM
BioElectronics EVP Dr. Deepak Kotak Interviewed on CEO Live "PR Newswire (US)" - 8/18/2014 7:20:00 PM
BioElectronics President Letter to Shareholders "PR Newswire (US)" - 8/4/2014 8:30:00 AM
BioElectronics "Try It and Tell Us" Facebook Social Media Program Builds Momentum and User Testimonials "PR Newswire (US)" - 6/30/2014 8:30:00 AM
BioElectronics' OTC ActiPatch® Musculoskeletal Pain Therapy Clinically Proven to Reduce Osteoarthritis Pain and Disability "PR Newswire (US)" - 5/14/2014 8:30:00 AM
Osteoarthritis Study shows ActiPatch® Therapy Significantly Relieves Knee Pain "PR Newswire (US)" - 4/16/2014 9:00:00 AM
Clear Channel Bus. Talk Radio's 'The Traders Network' Interview With Andrew J. Whelan, CEO of BioElectronics Corp Now Availab... "Marketwired" - 4/15/2014 9:55:11 AM
BioElectronics Device Alleviates Dental Surgical Trauma "PR Newswire (US)" - 3/25/2014 8:30:00 AM
BioElectronics CEO Andrew Whelan to Be Interviewed Live Wednesday on Clear Channel Business Talk Radio "Marketwired" - 3/24/2014 8:19:47 AM
Depository Trust Company (DTC) Lifts Chill on BioElectronics Shares "PR Newswire (US)" - 3/20/2014 8:30:00 AM
BioElectronics' ActiPatch® and Allay® are Now Available in Austria "PR Newswire (US)" - 3/18/2014 8:30:00 AM
BioElectronics Appoints Deepak Kotak, MD, Esq as Executive Vice President "PR Newswire (US)" - 3/11/2014 8:30:00 AM
BioElectronics Wins High Commendation In "Most Innovative New OTC Product Award" From OTC Bulletin "PR Newswire (US)" - 3/7/2014 9:49:00 AM
New Education Campaign Seeks to Teach Consumers, Medical Pros to Fight Pain Without Drugs "PR Newswire (US)" - 3/4/2014 8:30:00 AM
BioElectronics Researchers And Clinicians Support FDA's Position To Reclassify Shortwave Medical Devices To Class II "PR Newswire (US)" - 2/27/2014 9:32:00 AM
Google Plus to feature Dr. Christine Dumas on Wednesday, February 26th "PR Newswire (US)" - 2/26/2014 10:36:00 AM
BioElectronics Announces New Product "PR Newswire (US)" - 2/25/2014 8:30:00 AM
BioElectronics Applauds FDA Recommendation to Reclassify Shortwave Medical Devices to Class II "PR Newswire (US)" - 2/21/2014 8:30:00 AM
BioElectronics' Innovative Pain Relief Products Nominated for Most Innovative New OTC Product Award and Others by OTC Bulletin "PR Newswire (US)" - 2/18/2014 8:30:00 AM
Pain Management Medical Journal Features BioElectronics' Innovative Pain Products Because Pain is Not a Druggable Disease "PR Newswire (US)" - 1/9/2014 8:30:00 AM
BioElectronics Enters the $20 Billion Dental Market "PR Newswire (US)" - 12/30/2013 9:15:00 AM
BioElectronics' ActiPatch® Musculoskeletal Pain Therapy Now Available in Boots Stores "PR Newswire (US)" - 12/9/2013 8:30:00 AM
BioElectronics' RecoveryRx® and Smart Insole™ are Now Available in Austria "PR Newswire (US)" - 11/19/2013 8:30:00 AM
GEM Member Level  Friday, 02/21/14 10:55:46 AM
Re: BoilerRoom post# 32232
Post # of 42876 
BIEL~~FDA Approval news this AM....

BioElectronics Applauds FDA Recommendation to Reclassify Shortwave Medical Devices to Class II
FDA's Proposed Regulations Opens New US Markets

[21-February-2014]

FREDERICK, Md., Feb. 21, 2014 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of disposable drug-free healing pain therapy devices welcomed the FDA recommendations announced today in their Docket No. FDA-2012-N-0378, "Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses."
"We are pleased that the FDA is reclassifying this technology to reflect its safety and efficacy," said Andrew J. Whelan, President, BioElectronics. The FDA's recommendation makes scientific evidence the determinant for additional market clearances."
Whelan reported, we will be responding to the call for new 510K applications with our extensive published clinical data and with new clinical trial data generated from, randomized, placebo controlled studies conducted at some of the world's leading medical institutions. We are confident that our scientific and clinical data will enable us to obtain equivalent U.S. market clearances to those we have earned in Canada, the European Common Market and much of the rest of the world.
"We are grateful to our customers and shareholders for their input to the FDA in the process that lead to today's recommendation. U.S. consumers need ready access to this safe, drug-free and cost-effective technology that offers superior pain relief and accelerates healing," Whelan said.
About BioElectronics Corporation
BioElectronics is the leader in consumer medical devices that reduce pain, inflammation and accelerate healing. Its products are ActiPatch® Musculoskeletal Pain Therapy for back, knee, and other musculoskeletal complaints; RecoveryRx® for chronic and post-operative wound care; HealFast® Veterinary Therapy, Allay® Menstrual Pain Therapy and Smart Insole™ Heel Pain Therapy. Visit www.bielcorp.com for more information.
BioElectronics Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist